Medical devices -- Post-market surveillance for manufacturers

This document provides guidance on the post-market surveillance process and is intended for use by medical device manufacturers. This post-market surveillance process is consistent with relevant international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive and systematic process that manufacturers can use to collect and analyse appropriate data, to provide information for the feedback processes and use this to meet applicable regulatory requirements to gain experience from the post-production activities. The output of this process can be used: — as input into product realization; — as input into risk management; — for monitoring and maintaining product requirements; — for communicating to regulatory authorities; or — as input into improvement processes. This document does not address market surveillance activities to be performed by regulatory authorities. Neither does it specify a manufacturer's actions required by the applicable regulatory requirements resulting from their production or post-production activities, nor reporting to regulatory authorities. This document is not intended to replace or change applicable regulatory requirements for post-market surveillance.

Dispositifs médicaux -- Surveillance après mise sur le marché incombant aux fabricants

Le présent document fournit des recommandations relatives au processus de surveillance aprčs mise sur le marché et est destiné ŕ ętre utilisé par les fabricants de dispositifs médicaux. Ce processus de surveillance aprčs mise sur le marché est conforme aux normes internationales applicables, notamment l'ISO 13485 et l'ISO 14971. Le présent document décrit un processus proactif et systématique que les fabricants peuvent utiliser pour collecter et analyser des données appropriées, fournir des informations pour alimenter les processus de retours d'information et les utiliser pour satisfaire aux exigences réglementaires applicables afin d'acquérir de l'expérience ŕ partir des activités de postproduction. Le résultat de ce processus peut ętre utilisé: — comme élément d'entrée pour la réalisation du produit; — comme élément d'entrée pour la gestion des risques; — pour la surveillance et le respect des exigences relatives au produit; — pour la communication avec les autorités réglementaires; — comme élément d'entrée pour les processus d'amélioration. Le présent document ne traite pas des activités de surveillance du marché incombant aux autorités réglementaires. Il ne spécifie pas non plus les mesures requises de la part du fabricant par les exigences réglementaires applicables et découlant de ses activités de production ou de postproduction ni le signalement aux autorités réglementaires. Le présent document n'est pas destiné ŕ remplacer ni ŕ modifier les exigences réglementaires applicables ŕ la surveillance aprčs mise sur le marché.

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Published
Publication Date
07-Jul-2020
Current Stage
6000 - International Standard under publication
Start Date
08-Jul-2020
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TECHNICAL ISO/TR
REPORT 20416
First edition
2020-07
Medical devices — Post-market
surveillance for manufacturers
Dispositifs médicaux — Surveillance après mise sur le marché
incombant aux fabricants
Reference number
ISO/TR 20416:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TR 20416:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 20416:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Purpose of post-market surveillance process ....................................................................................................................... 2

5 Planning of post-market surveillance ............................................................................................................................................ 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Scope of the post-market surveillance plan ................................................................................................................... 4

5.3 Objective of the post-market surveillance plan .......................................................................................................... 5

5.4 Responsibilities and authorities .............................................................................................................................................. 7

5.5 Data collection ......................................................................................................................................................................................... 7

5.5.1 Data sources ......................................................................................................................................................................... 7

5.5.2 Defining data collection methods ...................................................................................................................... 8

5.5.3 Developing the data collection protocol ...................................................................................................... 9

5.6 Data analysis ............................................................................................................................................................................................. 9

5.6.1 General...................................................................................................................................................................................... 9

5.6.2 Considerations concerning planning the data analysis .................................................................. 9

5.6.3 Methods for data analysis ........................................................................................................................................ 9

5.7 Report on data analysis ................................................................................................................................................................10

5.8 Interface with other processes ...............................................................................................................................................11

6 Review of the post-market surveillance plan ......................................................................................................................12

6.1 Purpose of the review ....................................................................................................................................................................12

6.2 Criteria ........................................................................................................................................................................................................12

6.3 Review .........................................................................................................................................................................................................13

Annex A (informative) Examples of data sources .................................................................................................................................14

Annex B (informative) Examples of data analysis methods ......................................................................................................25

Annex C (informative) Examples of post-market surveillance plans ...............................................................................31

Bibliography .............................................................................................................................................................................................................................43

© ISO 2020 – All rights reserved iii
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ISO/TR 20416:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 210, Quality management and

corresponding general aspects for medical devices.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
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ISO/TR 20416:2020(E)
Introduction

As medical devices are designed, developed, manufactured and distributed on the global market, a

residual risk with regard to the medical device’s safety and performance remains throughout the

product life cycle. This is due to a combination of factors, such as product variability, factors affecting

the medical device’s use environment, the different end user interaction, as well as unforeseen medical

device failure or misuse. Design and development activities of medical devices ensure that the residual

risk is acceptable before product release (i.e. pre-market). However, it is important to collect and analyse

information on the medical device during production and post-production to meet requirements for

monitoring of product and processes and ensure the residual risk remains acceptable. Appropriate

processes for collecting and analysing the information on the production and post-production feedback

allows for early detection of any undesirable effects. These processes can also reveal opportunities for

improvement, as specified in ISO 13485, or possible relevance to safety, as specified in ISO 14971.

Post-market surveillance is the process to enable manufacturers to perform such monitoring, by

collecting data from actual use of medical devices, analysing these data and then using the information

from post-market surveillance in the appropriate processes, such as product realization, risk

management, communicating to regulatory authorities or product improvement. The extent of a post-

market surveillance process needs to be appropriate and proportionate to the medical device and its use.

The intent of this document is to provide guidance to manufacturers who are planning and executing

their post-market surveillance activities. Other organizations, such as importers, distributors and

reprocessors, that are connected to the manufacturer in the product lifecycle and who play a role in

post-market surveillance activities, can also utilize the guidance in this document for their activities.

In the rest of this document, the term organization will be used instead of manufacturer, as far as

applicable.

The guidance on the post-market surveillance process described in this document is complimentary

to requirements in ISO 13485 and ISO 14971 for production and post-production activities to conduct

post-market surveillance, see Figure 1.
© ISO 2020 – All rights reserved v
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ISO/TR 20416:2020(E)
Key
setting requirements
provide deliverables

Figure 1 — Inter-relationship of ISO TR 20416 with ISO 13485 and ISO 14971 standards

Decisions and actions, based on the information collected and analysed by application of this document,

are described in other standards, such as ISO 13485 and ISO 14971, and are therefore not included

in this document. The organization may be required to perform post-market surveillance activities

to fulfil applicable regulatory requirements for medical devices. While regulatory requirements

are not described here, this document can be helpful for organizations in fulfilling those regulatory

requirements. This document uses the definition of post-market surveillance from ISO 13485. Users

of this document should note that the use of terms with respect to post-production data can vary

in different jurisdictions and define different activities and responsibilities, for example market

surveillance.
vi © ISO 2020 – All rights reserved
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TECHNICAL REPORT ISO/TR 20416:2020(E)
Medical devices — Post-market surveillance for
manufacturers
1 Scope

This document provides guidance on the post-market surveillance process and is intended for use

by medical device manufacturers. This post-market surveillance process is consistent with relevant

international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive

and systematic process that manufacturers can use to collect and analyse appropriate data, to provide

information for the feedback processes and use this to meet applicable regulatory requirements to gain

experience from the post-production activities. The output of this process can be used:

— as input into product realization;
— as input into risk management;
— for monitoring and maintaining product requirements;
— for communicating to regulatory authorities; or
— as input into improvement processes.

This document does not address market surveillance activities to be performed by regulatory

authorities. Neither does it specify a manufacturer’s actions required by the applicable regulatory

requirements resulting from their production or post-production activities, nor reporting to regulatory

authorities. This document is not intended to replace or change applicable regulatory requirements for

post-market surveillance.
2 Normative references
There are no normative references for this document.
3 Terms and definitions

For the purpose of this document, the definitions given in ISO 14971:2019 and ISO 13485:2016 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
post-market clinical follow-up study
PMCF-study

study carried out following marketing approval intended to answer specific questions relating to

clinical safety or performance (i.e. residual risks) of a medical device when used in accordance with its

approved labelling

Note 1 to entry: These may examine issues such as long-term performance, the appearance of clinical events

(such as delayed hypersensitivity reactions or thrombosis), events specific to defined patient populations, or the

performance of the medical device in a more representative population of providers and patients.

© ISO 2020 – All rights reserved 1
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ISO/TR 20416:2020(E)
[SOURCE: GHTF/SG5/N4: 2010, modified — "device" changed to "medical device"]

Note 2 to entry: For in-vitro diagnostics, a similar type of studies exists, e.g. post-market performance follow-up

(PMPF) study in Europe.
3.2
post-market surveillance

systematic process to collect and analyse experience gained from medical devices that have been placed

on the market
[SOURCE: ISO 13485:2016, 3.14]
4 Purpose of post-market surveillance process

In accordance with the requirements outlined in ISO 13485:2016, Clause 8 and ISO 14971:2019,

Clause 10, the organization documents one or more processes for collecting and analysing data from

production and post-production activities. This information can then be used as input into product

realization, risk management processes, determination of achievement of quality objectives or other

actions for improvement.

Post-market surveillance can also identify new opportunities for improvement associated with the

medical device in accordance with ISO 13485. It also provides the input for the risk management

process in accordance to ISO 14971. Furthermore, it provides input into the design and development

change processes, in accordance to ISO 13485.
Post-market surveillance serves the following main purposes:

— Monitoring medical device safety and performance: Post-market surveillance links to other processes

established in the quality management system, including, but not limited to, feedback, analysis of

data, improvement, design and development processes, including design and development inputs,

risk management, clinical evaluation or performance evaluation. Post-market surveillance activities

help to ensure that available data are analysed and utilized to help make determinations about the

safety and performance of a medical device in accordance with the intended use.

— Meeting regulatory requirements: This document contains suggestions and techniques that can be

used to meet the applicable regulatory requirements. This can include analysing and reviewing

information to gain specific experience from production and post-production activities, trending

of processes and product, as well as feedback to the organisation for improvement activities, as

specified in the applicable regulatory requirements.

— Contributing to life cycle management: Post-market surveillance can also identify if the medical

device is not current state of the art, based on the information from medical devices used for similar

purposes, the evolution to the state of the art, or alternative medical treatment procedures. These

signals can trigger a design modification, a change in intended use or purpose, a new medical device

design or removal of the medical device from the market. Post-market surveillance can generate

real world information that can be leveraged either to obtain new marketing authorizations for the

medical device (new markets, new indications supported by actual use of the medical device), or of

the next generation of medical device.

Figure 2 explains the position of post-market surveillance in the quality management system and its

relationship with the other processes.

NOTE Figure 2 is a more detailed representation of phases I and II from Figure 4 provided in the

ISO 13485:2016 Medical Device - A practical guide, Advice from ISO/TC210.
2 © ISO 2020 – All rights reserved
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ISO/TR 20416:2020(E)
Figure 2 — Example schematic representation of post-market surveillance
5 Planning of post-market surveillance
5.1 General

The post-market surveillance plan defines how the organization intends to actively collect and analyse

relevant data from the use of the medical device throughout the life cycle. Figure 2 outlines how the

post-market surveillance process interacts with other processes in a quality management system.

NOTE If a quality management system is not established, the same principles apply, although the processes

can be organized differently.
© ISO 2020 – All rights reserved 3
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ISO/TR 20416:2020(E)

The organization should ensure post-market surveillance activities are carried out in line with

documented methods and that the results of such activities are evaluated and reported to top

management.

The post-market surveillance activities should be planned before the first placing on the market of the

medical device and updated as necessary during product life cycle (see Clause 6).

A documented plan for post-market surveillance addresses the following:
— scope of the post-market surveillance plan (see 5.2);
— objective of the post-market surveillance plan (see 5.3);
— responsibilities and authorities (see 5.4);
— data collection (see 5.5);
— data analysis (see 5.6);
— report on data analysis (see 5.7);
— review of the post-market surveillance plan (see Clause 6).

The extent of post-market surveillance activities will depend upon several factors, such as the risks

associated with the medical device, the chosen data sources or the expected robustness of the available

information on safety and performance.

The post-market surveillance plan provides details on how the following clauses of this document

are addressed for the medical device or medical device family subject to the plan. The post-market

surveillance plan also addresses the methods used to collect and analyse available data in order to

provide information for other relevant processes.

The plan, as well as any data, information and reports generated according to the plan are considered

documents or records, see ISO 13485:2016, 4.2.4 and 4.2.5.

An approved post-market surveillance plan should be contained within one or more documents

within the quality management system and may include references to other documents or procedures

containing post-market surveillance activities.

Post-market surveillance plans should consider input from a cross-functional team, see 5.4.

5.2 Scope of the post-market surveillance plan

The scope of the post-market surveillance plan depends on the type of the medical device. The following

non-exhaustive list of factors should be considered when defining the scope:
— the medical device type or medical device family, including accessories;
— regulatory classification;
— jurisdictions where the medical device is available;

— expected lifetime of the medical device, expected number of uses or usage frequency of the medical

device (single use vs. reusable instrument);
— the intended use;

— the available data related to safety and performance of the medical device, including clinical data;

— life cycle stage with regard to product and technology maturity in relation to state of the art.

By considering these examples and appropriately scoping the plan, the amount of resulting information

and data should be sufficient to confirm post-production safety and performance.
4 © ISO 2020 – All rights reserved
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ISO/TR 20416:2020(E)
5.3 Objective of the post-market surveillance plan

Regardless of the extent of design and development verification and validation activities, there will

always be some uncertainty about the safety and performance of the medical device during its life

cycle. The objectives of the post-market surveillance plan include reducing the identified uncertainty

by collecting and analysing new relevant information.

The post-market surveillance plan sets the objectives for the post-market surveillance activities in

relation with the medical device life cycle, the specification of the medical device, the intended use or

application and the applicable regulatory requirements in different markets. The plan should identify

the type and adequacy of information to be collected in order to satisfy the objectives. They can address

various aspects of the medical device, such as safety and performance including usability, labelling,

market adoption, user feedback and any other opportunities for improvement.

On defining the objectives of the post-market surveillance plan, the organization should specify the

associated measurable criteria, alert and action levels, as appropriate (see also 5.6).

The questions below can help formulate the objectives:

— Has any new hazard or hazardous situation been identified for the medical device or similar medical

devices or has the risk acceptability changed?
— Has any misuse of the medical device occurred?

— Does the medical device meet the user’s needs after medium/long term clinical use?

— Are there any unforeseen side effects for the medical device or similar medical devices?

— Are there any improvements that can be made to the medical device?

— Has state of the art changed after design and development of the medical device?

— Does the patient’s average age at medical device implantation, affect the medical device lifetime?

— Can user/patient training reduce the likelihood of malfunction?
— Is there a medical device malfunction that impacts the benefit-risk analysis?

— Are indications or contra-indications appropriate to ensure safety and effectiveness for the intended

use of the medical device?
— Do users experience any usability issues?
— Are recurring malfunctions due to service/maintenance deficiencies?

— Can significant increasing/decreasing trends be identified for a specific medical device malfunction

representing a possible source of harm?
— Is the expected lifetime correct?
— How does treatment affect the quality of life of the patient?

Table 1 and the example plans in Annex C provide more specific examples of objectives. The examples

given in Table 1 illustrate how some situations can lead to different objectives of a post-market

surveillance plan.
© ISO 2020 – All rights reserved 5
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ISO/TR 20416:2020(E)
Table 1 — Examples of post-market surveillance plan objectives.
Input process Situation Possible objectives post-market
surveillance plan

Design and development A new medical device that has just Monitor the safety and performance

been granted market approval. on a more frequent basis, than for
an established medical device for a
limited period of time, as defined by
the organization.
Ensure that the links between the
clinical evaluation, pre-clinical stud-
ies and risk management processes
are robust and transparent.

Risk management Commercial launch of a surgical Continue to monitor the safety, per-

instrument specifically developed for formance and usability of the medi-
surgeons to perform the implanta- cal device to characterize the degree
tion of a medical device according to of satisfaction of the surgeons with
a break-through surgical technique. the medical device and their ability
The surgical instrument itself has a to reliably perform the surgical tech-
similar risk profile to other surgical nique using the surgical instrument.
instruments on the market.
Ensure that the links between the
clinical evaluation and risk man-
agement processes are robust and
transparent.

Clinical evaluation/ perfor- An implantable medical device for Obtain information on the long-term

mance evaluation which a clinical investigation was safety and performance of the medi-

performed to establish the short-term cal device, including clinical benefits,
safety and performance of the medi- which can be part of a PMCF-study.
cal device.
Confirm the prevalence of known or
See also ISO 14155: 2019 and suspected adverse events.
ISO 20916 (for in-vitro diagnostic
medical devices).

Regulatory Information from a user suggests that Invoke company feedback procedures

an existing medical device is being to further investigate this issue.
used for an indication not included in Collect data on the prevalence of
the instructions for use. the use and assess if current clinical
data supports the new usage. Other
actions can be considered necessary,
such as updating technical documen-
tation, evaluating the risk associated
with the new intended use.

Improvement Medical device already on the market Monitor continued satisfaction of the

for several years, in the maturity users with the medical device and
phase of its life cycle. the evolution of the state of the art.
Obtain feedback for improvement.,
not necessarily related to safety and
performance issues.

Marketing and sales An organization intends to market an Ensure appropriate usability data are

existing medical device for use in the being collected and that the medical
home environment in addition to the device is appropriate for home use
hospital. with the target patient population
before extending the intended use.
Consider new stakeholders as a
source of data, such as community
nurses and general practitioners.

Annex C contains several detailed examples of post-market surveillance activities for different types of

medical devices, including the objectives for these situations.
6 © ISO 2020 – All rights reserved
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ISO/TR 20416:2020(E)
5.4 Responsibilities and authorities

Top management should define, assign and communicate responsibilities and authorities for post-

market surveillance activities and should ensure the availability of resources with the independence

and competence for post-market surveillance activities. The post-market surveillance team should

include cross-functional representatives, for example resources from design and development, risk

management, quality assurance, complaint handling, returned medical device analysis, product

evaluation (clinical and performance), production, marketing and sales, regulatory, or service. It

should be noted, that the number of people involved largely depends on the size of the organization, the

complexity or perceived risk of the medical device and the responsibilities of each person.

The assignment of responsibilities and determination of required competence can be developed into a

resource allocation matrix, as shown in Table 2. The organization may choose to use external resources

(see also ISO 13485:2016, 4.1.5), provided those responsibilities are detailed in an appropriate written

quality agreement.
Table 2 — Example of post-market surveillance resources allocation matrix.
Post-market surveillance Responsible functions Competence
activity
Post-market surveillance plan Organization management The medical device and its
development and execution use, clinical/safety matters re-
lated to the medical device or
the organization’s post-mar-
ket surveillance process
Post-production incident Complaint handling Complaint handling and ad-
handling verse event reporting
Data analysis Statistics Quantitative statistical meth-
ods required for analysis of
colle
...

RAPPORT ISO/TR
TECHNIQUE 20416
Première édition
2020-07
Dispositifs médicaux — Surveillance
après mise sur le marché incombant
aux fabricants
Medical devices — Post-market surveillance for manufacturers
Numéro de référence
ISO/TR 20416:2020(F)
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TR 20416:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
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Publié en Suisse
ii © ISO 2020 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO/TR 20416:2020(F)
Sommaire Page

Avant-propos ..............................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Objectif du processus de surveillance après mise sur le marché ......................................................................2

5 Planification de la surveillance après mise sur le marché ....................................................................................... 4

5.1 Généralités .................................................................................................................................................................................................. 4

5.2 Domaine d’application du plan de surveillance après mise sur le marché ......................................... 5

5.3 Objectif du plan de surveillance après mise sur le marché .............................................................................. 5

5.4 Responsabilités et autorités ........................................................................................................................................................ 7

5.5 Collecte des données .......................................................................................................................................................................... 8

5.5.1 Sources de données ....................................................................................................................................................... 8

5.5.2 Définition des méthodes de collecte de données ................................................................................. 9

5.5.3 Élaboration du protocole de collecte des données ............................................................................. 9

5.6 Analyse des données .......................................................................................................................................................................10

5.6.1 Généralités .........................................................................................................................................................................10

5.6.2 Considérations relatives à la planification de l’analyse des données ..............................10

5.6.3 Méthodes d’analyse des données ...................................................................................................................10

5.7 Rapport d’analyse des données .............................................................................................................................................11

5.8 Interface avec d’autres processus ........................................................................................................................................13

6 Revue du plan de surveillance après mise sur le marché .......................................................................................13

6.1 Objet de la revue .................................................................................................................................................................................13

6.2 Critères........................................................................................................................................................................................................13

6.3 Revue ............................................................................................................................................................................................................14

Annexe A (informative) Exemples de sources de données .........................................................................................................15

Annexe B (informative) Exemples de méthodes d’analyse des données ......................................................................27

Annexe C (informative) Exemples de plans de surveillance après mise sur le marché ................................34

Bibliographie ...........................................................................................................................................................................................................................47

© ISO 2020 – Tous droits réservés iii
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ISO/TR 20416:2020(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www .iso .org/ avant -propos.

Le présent document a été élaboré par le comité technique 210, Management de la qualité et aspects

généraux correspondants des dispositifs médicaux.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
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ISO/TR 20416:2020(F)
Introduction

Lors de la conception, du développement, de la fabrication et de la distribution des dispositifs médicaux

sur le marché mondial, il subsiste un risque résiduel au regard de la sécurité et des performances du

dispositif médical tout au long du cycle de vie du produit. Cela est dû à une combinaison de facteurs,

comme la variabilité du produit, des facteurs influant sur l’environnement d’utilisation du dispositif

médical, les différentes interactions avec l’utilisateur final ainsi que les défaillances ou utilisations

abusives imprévues du dispositif médical. Les activités de conception et de développement des

dispositifs médicaux garantissent que le risque résiduel est acceptable avant le lancement du produit (à

savoir, avant mise sur le marché). Cependant, il est important de collecter et d’analyser les informations

relatives au dispositif médical pendant et après la production afin de satisfaire aux exigences de

surveillance du produit et des processus et de garantir que le risque résiduel reste acceptable. Des

processus appropriés de collecte et d’analyse des informations relatives à la production et des retours

d’information sur la postproduction permettent une détection précoce de tout effet indésirable. Ces

processus peuvent également permettre d’identifier des opportunités d’amélioration, comme spécifié

dans l’ISO 13485, ou une éventuelle pertinence en matière de sécurité, comme spécifié dans l’ISO 14971.

La surveillance après mise sur le marché est le processus qui permet aux fabricants d’effectuer cette

surveillance en collectant des données sur l’utilisation effective des dispositifs médicaux, en analysant

ces données et en utilisant ensuite les informations obtenues de la surveillance après mise sur le

marché dans les processus appropriés, tels que la réalisation du produit, la gestion des risques, la

communication avec les autorités réglementaires ou l’amélioration du produit. Il est nécessaire que

l’étendue d’un processus de surveillance après mise sur le marché soit appropriée et proportionnée au

dispositif médical et à son utilisation.

Le présent document a pour objectif de fournir des recommandations à l’attention des fabricants

dans le cadre de la planification et de la mise en œuvre de leurs activités de surveillance après mise

sur le marché. D’autres organismes, tels que les importateurs, les distributeurs et les entreprises de

retraitement, qui sont en lien avec le fabricant au cours du cycle de vie du produit et qui jouent un

rôle dans les activités de surveillance après mise sur le marché, peuvent également utiliser les

recommandations du présent document pour leurs activités. Dans le reste du présent document, le

terme «organisme» sera utilisé en lieu et place de «fabricant», autant que faire se peut.

Les recommandations relatives au processus de surveillance après mise sur le marché décrit dans le

présent document s’ajoutent aux exigences énoncées dans l’ISO 13485 et l’ISO 14971 concernant les

activités de production et de postproduction destinées à mettre en place une surveillance après mise

sur le marché; voir Figure 1.
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ISO/TR 20416:2020(F)
Légende
établissements d’exigences
fourniture de livrables
Figure 1 — Corrélation entre l’ISO TR 20416 et les normes ISO 13485 et ISO 14971

Les décisions et mesures prises sur la base des informations collectées et analysées en application du

présent document sont décrites dans d’autres normes, telles que l’ISO 13485 et l’ISO 14971, et ne sont

donc pas abordées dans le présent document. Il peut être exigé que l’organisme mette en œuvre des

activités de surveillance après mise sur le marché en vue de satisfaire à des exigences réglementaires

applicables aux dispositifs médicaux. Bien qu’aucune exigence réglementaire ne soit décrite dans le

présent document, ce dernier peut être utile pour aider les organismes à satisfaire auxdites exigences.

Le présent document utilise la définition de la surveillance après mise sur le marché telle qu’énoncée

dans l’ISO 13485. Il convient que les utilisateurs du présent document tiennent compte du fait que

l’utilisation des termes relatifs aux données de postproduction peut varier d’une juridiction à l’autre et

que ceux-ci peuvent définir différentes activités et responsabilités, telles que la surveillance du marché.

vi © ISO 2020 – Tous droits réservés
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RAPPORT TECHNIQUE ISO/TR 20416:2020(F)
Dispositifs médicaux — Surveillance après mise sur le
marché incombant aux fabricants
1 Domaine d’application

Le présent document fournit des recommandations relatives au processus de surveillance après mise

sur le marché et est destiné à être utilisé par les fabricants de dispositifs médicaux. Ce processus de

surveillance après mise sur le marché est conforme aux normes internationales applicables, notamment

l’ISO 13485 et l’ISO 14971. Le présent document décrit un processus proactif et systématique que les

fabricants peuvent utiliser pour collecter et analyser des données appropriées, fournir des informations

pour alimenter les processus de retours d’information et les utiliser pour satisfaire aux exigences

réglementaires applicables afin d’acquérir de l’expérience à partir des activités de postproduction. Le

résultat de ce processus peut être utilisé:
— comme élément d’entrée pour la réalisation du produit;
— comme élément d’entrée pour la gestion des risques;
— pour la surveillance et le respect des exigences relatives au produit;
— pour la communication avec les autorités réglementaires;
— comme élément d’entrée pour les processus d’amélioration.

Le présent document ne traite pas des activités de surveillance du marché incombant aux autorités

réglementaires. Il ne spécifie pas non plus les mesures requises de la part du fabricant par les exigences

réglementaires applicables et découlant de ses activités de production ou de postproduction ni le

signalement aux autorités réglementaires. Le présent document n’est pas destiné à remplacer ni à

modifier les exigences réglementaires applicables à la surveillance après mise sur le marché.

2 Références normatives
Le présent document ne contient aucune référence normative.
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions donnés dans l’ISO 14971:2019 et

l’ISO 13485:2016, ainsi que les suivants s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp;

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/ .
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ISO/TR 20416:2020(F)
3.1
étude de suivi clinique après mise sur le marché
étude PMCF (de l’anglais «post-market clinical follow-up»)

étude réalisée après l’autorisation de mise sur le marché destinée à répondre à des questions spécifiques

relatives à la sécurité clinique ou aux performances (c’est-à-dire aux risques résiduels) d’un dispositif

médical lorsqu’il est utilisé conformément à son étiquetage approuvé

Note 1 à l'article: Ces études peuvent examiner des problématiques telles que les performances à long terme,

l’apparition d’événements cliniques (tels que des réactions d’hypersensibilité retardée ou des thromboses)

ou d’événements spécifiques à des populations de patients définies, ou encore les performances du dispositif

médical dans une population de prestataires de soins de santé et de patients plus représentative.

[SOURCE: GHTF/SG5/N4: 2010, modifiée — «dispositif» a été remplacé par «dispositif médical»]

Note 2 à l'article: Pour les diagnostics in vitro, un type d’études similaire existe, à savoir l’étude de suivi des

performances après mise sur le marché (PMPF) en Europe.
3.2
surveillance après mise sur le marché

processus systématique de recueil et d’analyse de l’expérience acquise à partir des dispositifs médicaux

qui ont été mis à disposition
[SOURCE: ISO 13485:2016, 3.14]
4 Objectif du processus de surveillance après mise sur le marché

Conformément aux exigences énoncées dans l’ISO 13485:2016, Article 8, et l’ISO 14971:2019, Article 10,

l’organisme documente un ou plusieurs processus de collecte et d’analyse des données provenant des

activités de production et de postproduction. Ces informations peuvent ensuite être utilisées comme

éléments d’entrée pour la réalisation du produit, les processus de gestion des risques, l’évaluation de la

réalisation des objectifs de qualité ou d’autres mesures d’amélioration.

La surveillance après mise sur le marché peut également identifier de nouvelles opportunités

d’amélioration liées au dispositif médical, conformément à l’ISO 13485. Elle fournit également un

élément d’entrée pour le processus de gestion des risques, conformément à l’ISO 14971. Elle apporte

en outre un élément d’entrée pour les processus de changement de la conception et du développement,

conformément à l’ISO 13485.

La surveillance après mise sur le marché répond aux principaux objectifs suivants:

— Surveillance de la sécurité et des performances du dispositif médical: la surveillance après mise sur

le marché est associée à d’autres processus établis dans le cadre du système de management de la

qualité, y compris, sans toutefois s’y limiter, les retours d’information, l’analyse des données, les

processus d’amélioration, de conception et de développement, incluant les éléments d’entrée de

conception et de développement, la gestion des risques, l’évaluation clinique ou l’évaluation des

performances. Les activités de surveillance après mise sur le marché contribuent à garantir que les

données disponibles sont analysées et utilisées en vue d’aider à la détermination de la sécurité et

des performances d’un dispositif médical conformément à son utilisation prévue.

— Satisfaction aux exigences réglementaires: le présent document contient des suggestions et

techniques qui peuvent être utilisées pour satisfaire aux exigences réglementaires applicables. Cela

peut comprendre l’analyse et la revue des informations en vue d’acquérir une expérience spécifique

des activités de production et de postproduction, des tendances des processus et des produits, ainsi

que des retours d’information à l’organisme pour les activités d’amélioration, comme spécifié dans

les exigences réglementaires applicables.

— Contribution à la gestion du cycle de vie: la surveillance après mise sur le marché peut également

permettre d’identifier que le dispositif médical ne correspond plus à l’état de l’art actuel en

s’appuyant sur des informations issues de dispositifs médicaux utilisés à des fins similaires, sur

l’évolution de l’état de l’art ou sur des procédures de traitement médical alternatives. Ces indications

2 © ISO 2020 – Tous droits réservés
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ISO/TR 20416:2020(F)

peuvent entraîner une modification de la conception, une modification de l’utilisation prévue ou de la

destination, une nouvelle conception du dispositif médical ou son retrait du marché. La surveillance

après mise sur le marché peut produire des informations issues du monde réel qui peuvent être

exploitées soit pour obtenir de nouvelles autorisations de mise sur le marché du dispositif médical

(nouveaux marchés, nouvelles indications d’utilisation du dispositif médical soutenues par son

utilisation sur le terrain), soit pour concevoir la prochaine génération de dispositif médical.

La Figure 2 explique le rôle de la surveillance après mise sur le marché dans le système de management

de la qualité et sa relation avec les autres processus.

NOTE La Figure 2 est une représentation plus détaillée des phases I et II de la Figure 4 fournie dans le

manuel «ISO 13485:2016 Medical Device — A practical guide, Advice from ISO/TC210».

Figure 2 — Exemple de représentation schématique de la surveillance après mise sur le marché

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ISO/TR 20416:2020(F)
5 Planification de la surveillance après mise sur le marché
5.1 Généralités

Le plan de surveillance après mise sur le marché définit la manière dont l’organisme entend collecter

et analyser activement les données pertinentes provenant de l’utilisation du dispositif médical tout au

long de son cycle de vie. La Figure 2 présente la manière dont le processus de surveillance après mise

sur le marché interagit avec d’autres processus dans un système de management de la qualité.

NOTE Si aucun système de management de la qualité n’est établi, les mêmes principes s’appliquent, mais les

processus peuvent alors être organisés différemment.

Il convient que l’organisme s’assure que les activités de surveillance après mise sur le marché sont

mises en œuvre conformément à des méthodes documentées et que les résultats de ces activités soient

évalués et communiqués à la direction.

Il convient que les activités de surveillance après mise sur le marché soient planifiées avant le premier

placement du dispositif médical sur le marché et mises à jour si nécessaire au cours du cycle de vie du

produit (voir Article 6).

Un plan documenté de surveillance après mise sur le marché inclut les éléments suivants:

— le domaine d’application du plan de surveillance après mise sur le marché (voir 5.2);

— les objectifs du plan de surveillance après mise sur le marché (voir 5.3);
— les responsabilités et autorités (voir 5.4);
— la collecte des données (voir 5.5);
— l’analyse des données (voir 5.6);
— le rapport d’analyse des données (voir 5.7);
— la revue du plan de surveillance après mise sur le marché (voir Article 6).

L’étendue des activités de surveillance après mise sur le marché dépend de plusieurs facteurs, tels que

les risques associés au dispositif médical, les sources de données choisies ou la fiabilité escomptée des

informations disponibles sur la sécurité et les performances.

Le plan de surveillance après mise sur le marché fournit des détails sur la manière dont les articles

suivants du présent document sont traités en fonction du dispositif médical ou de la famille de

dispositifs médicaux faisant l’objet du plan. Le plan de surveillance après mise sur le marché comprend

également les méthodes utilisées pour collecter et analyser les données disponibles afin de fournir des

informations pour d’autres processus pertinents.

Le plan, ainsi que les données, informations et rapports générés conformément au plan, sont considérés

comme des documents ou enregistrements; voir ISO 13485:2016, 4.2.4 et 4.2.5.

Il convient qu’un plan de surveillance après mise sur le marché approuvé fasse partie d’un ou plusieurs

documents du système de management de la qualité et il est admis que ce plan contienne des références

à d’autres documents ou procédures intégrant des activités de surveillance après mise sur le marché.

Il convient que les plans de surveillance après mise sur le marché prennent en compte les données

d’entrée apportées par une équipe multidisciplinaire, voir 5.4.
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ISO/TR 20416:2020(F)
5.2 Domaine d’application du plan de surveillance après mise sur le marché

Le domaine d’application du plan de surveillance après mise sur le marché dépend du type de dispositif

médical. Lors de la définition du domaine d’application, il convient de considérer la liste non exhaustive

suivante de facteurs:

— le type de dispositif médical ou la famille de dispositifs médicaux, y compris les accessoires;

— la classification réglementaire;
— les juridictions dans lesquelles le dispositif médical est disponible;

— la durée de vie attendue du dispositif médical, le nombre d’utilisations ou la fréquence d’utilisation

attendus du dispositif médical (instrument à usage unique ou réutilisable);
— l’utilisation prévue;

— les données disponibles en matière de sécurité et de performance du dispositif médical, y compris

les données cliniques;

— l’étape du cycle de vie au regard de la maturité du produit et de la technologie par rapport à l’état

de l’art.

En considérant ces exemples et en définissant convenablement le domaine d’application du plan, il

convient que le volume d’informations et de données obtenues soit suffisant pour confirmer la sécurité

et les performances postproduction.
5.3 Objectif du plan de surveillance après mise sur le marché

Quelle que soit l’étendue des activités de vérification et de validation de la conception et du

développement, une certaine incertitude subsiste encore quant à la sécurité et aux performances du

dispositif médical au cours de son cycle de vie. Les objectifs du plan de surveillance après mise sur

le marché comprennent la réduction de l’incertitude identifiée par la collecte et l’analyse de nouvelles

informations pertinentes.

Le plan de surveillance après mise sur le marché définit les objectifs pour les activités de surveillance

après mise sur le marché liées au cycle de vie du dispositif médical, aux spécifications du dispositif

médical, à l’utilisation ou à l’application prévue et aux exigences réglementaires applicables sur

différents marchés. Il convient d’identifier le type et la pertinence des informations à collecter afin

de satisfaire aux objectifs. Celles-ci peuvent aborder divers aspects du dispositif médical, tels que la

sécurité et les performances, incluant l’aptitude à l’utilisation, l’étiquetage, l’adoption par le marché, les

retours d’information des utilisateurs et toutes autres opportunités d’amélioration.

Lors de la définition des objectifs du plan de surveillance après mise sur le marché, il convient que

l’organisme spécifie les critères mesurables associés ainsi que les niveaux d’alerte et d’action, suivant le

cas (voir également 5.6).
Les questions ci-dessous peuvent aider à la formulation des objectifs:

— Tous les dangers ou toutes les situations dangereuses ont-ils été identifiés pour le dispositif médical

ou des dispositifs médicaux similaires, ou l’acceptabilité du risque a-t-elle changé?

— Y a-t-il eu une utilisation inadéquate du dispositif médical?

— Le dispositif médical répond-il aux besoins de l’utilisateur suite à une utilisation clinique à moyen/

long terme?

— Y a-t-il des effets secondaires inattendus pour le dispositif médical ou des dispositifs médicaux

similaires?
— Des améliorations peuvent-elles être apportées au dispositif médical?
© ISO 2020 – Tous droits réservés 5
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ISO/TR 20416:2020(F)

— L’état de l’art a-t-il évolué depuis la conception et le développement du dispositif médical?

— La moyenne d’âge des patients au moment de l’implantation du dispositif médical a-t-elle une

influence sur la durée de vie du dispositif médical?

— La formation de l’utilisateur/du patient peut-elle réduire la probabilité de dysfonctionnement?

— Existe-t-il un dysfonctionnement du dispositif médical qui influe sur l’analyse bénéfice/risque?

— Les indications ou contrindications sont-elles appropriées pour garantir la sécurité et l’efficacité

conformément à l’utilisation prévue du dispositif médical?

— Les utilisateurs sont-ils confrontés à des problèmes d’aptitude à l’utilisation?

— Existe-t-il des dysfonctionnements récurrents dus à des défauts d’entretien/de maintenance?

— Des tendances en hausse/en baisse notables peuvent-elles être identifiées pour un dysfonctionnement

spécifique du dispositif médical représentant une potentielle source de dommage?
— La durée de vie attendue est-elle correcte?
— De quelle manière le traitement affecte-t-il la qualité de vie du patient?

Le Tableau 1 et les exemples de plans donnés dans l’Annexe C fournissent des exemples d’objectifs plus

spécifiques. Les exemples donnés dans le Tableau 1 illustrent la manière dont certaines situations

peuvent conduire à l’établissement d’objectifs pour un plan de surveillance après mise sur le marché.

Tableau 1 — Exemples d’objectifs de plan de surveillance après mise sur le marché

Objectifs possibles du plan de surveillance
Processus d’entrée Situation
après mise sur le marché

Conception et Nouveau dispositif médical auquel une Surveiller la sécurité et les performances sur

développement autorisation de mise sur le marché une base plus fréquente que pour un dispositif

vient juste d’être octroyée. médical établi pendant une durée limitée
définie par l’organisme.
S’assurer que les liens entre l’évaluation
clinique, les études précliniques et les
processus
...

TECHNICAL ISO/TR
REPORT 20416
First edition
Medical devices — Post-market
surveillance for manufacturers
PROOF/ÉPREUVE
Reference number
ISO/TR 20416:2020(E)
ISO 2020
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ISO/TR 20416:2020(E)
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
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ISO/TR 20416:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Purpose of post-market surveillance process ....................................................................................................................... 2

5 Planning of post-market surveillance ............................................................................................................................................ 3

5.1 General ........................................................................................................................................................................................................... 3

5.2 Scope of the post-market surveillance plan ................................................................................................................... 4

5.3 Objective of the post-market surveillance plan .......................................................................................................... 5

5.4 Responsibilities and authorities .............................................................................................................................................. 7

5.5 Data collection ......................................................................................................................................................................................... 7

5.5.1 Data sources ......................................................................................................................................................................... 7

5.5.2 Defining data collection methods ...................................................................................................................... 8

5.5.3 Developing the data collection protocol ...................................................................................................... 9

5.6 Data analysis ............................................................................................................................................................................................. 9

5.6.1 General...................................................................................................................................................................................... 9

5.6.2 Considerations concerning planning the data analysis .................................................................. 9

5.6.3 Methods for data analysis ........................................................................................................................................ 9

5.7 Report on data analysis ................................................................................................................................................................10

5.8 Interface with other processes ...............................................................................................................................................11

6 Review of the post-market surveillance plan ......................................................................................................................12

6.1 Purpose of the review ....................................................................................................................................................................12

6.2 Criteria ........................................................................................................................................................................................................12

6.3 Review .........................................................................................................................................................................................................13

Annex A (informative) Examples of data sources .................................................................................................................................14

Annex B (informative) Examples of data analysis methods ......................................................................................................25

Annex C (informative) Examples of post-market surveillance plans ...............................................................................31

Bibliography .............................................................................................................................................................................................................................43

© ISO 2020 – All rights reserved PROOF/ÉPREUVE iii
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ISO/TR 20416:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee 210, Quality management and corresponding

general aspects for medical devices.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv PROOF/ÉPREUVE © ISO 2020 – All rights reserved
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ISO/TR 20416:2020(E)
Introduction

As medical devices are designed, developed, manufactured and distributed on the global market, a

residual risk with regard to the medical device’s safety and performance remains throughout the

product life cycle. This is due to a combination of factors, such as product variability, factors affecting

the medical device’s use environment, the different end user interaction, as well as unforeseen medical

device failure or misuse. Design and development activities of medical devices ensures that the residual

risk is acceptable before product release (i.e. pre-market). However, it is important to collect and analyse

information on the medical device during production and post-production to meet requirements for

monitoring of product and processes and ensure the residual risk remains acceptable. Appropriate

processes for collecting and analysing the information on the production and post-production feedback

allows for early detection of any undesirable effects. These processes can also reveal opportunities for

improvement, as specified in ISO 13485, or possible relevance to safety, as specified in ISO 14971.

Post-market surveillance is the process to enable manufacturers to perform such monitoring, by

collecting data from actual use of medical devices, analysing these data and then using the information

from post-market surveillance in the appropriate processes, such as product realization, risk

management, communicating to regulatory authorities or product improvement. The extent of a post-

market surveillance process needs to be appropriate and proportionate to the medical device and its use.

The intent of this document is to provide guidance to manufacturers who are planning and executing

their post-market surveillance activities. Other organizations, such as importers, distributors and

reprocessors, that are connected to the manufacturer in the product lifecycle and who play a role in

post-market surveillance activities, can also utilize the guidance in this document for their activities.

In the rest of this document, the term organization will be used instead of manufacturer, as far as

applicable.

The guidance on the post-market surveillance process described in this document is complimentary

to requirements in ISO 13485 and ISO 14971 for production and post-production activities to conduct

post-market surveillance, see Figure 1.
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ISO/TR 20416:2020(E)
Key
1 setting requirements
2 provide deliverables

Figure 1 — Inter-relationship of ISO TR 20416 with ISO 13485 and ISO 14971 standards

Decisions and actions, based on the information collected and analysed by application of this document,

are described in other standards, such as ISO 13485 and ISO 14971, and are therefore not included

in this document. The organization may be required to perform post-market surveillance activities

to fulfil applicable regulatory requirements for medical devices. While regulatory requirements

are not described here, this document can be helpful for organizations in fulfilling those regulatory

requirements. This TR uses the definition of post-market surveillance from ISO 13485. Users of this

standard should note that the use of terms with respect to post-production data can vary in different

jurisdictions and define different activities and responsibilities, for example market surveillance.

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TECHNICAL REPORT ISO/TR 20416:2020(E)
Medical devices — Post-market surveillance for
manufacturers
1 Scope

This document provides guidance on the post-market surveillance process and is intended for use

by medical device manufacturers. This post-market surveillance process is consistent with relevant

international standards, in particular ISO 13485 and ISO 14971. This document describes a proactive

and systematic process that manufacturers can use to collect and analyse appropriate data, to provide

information for the feedback processes and use this to meet applicable regulatory requirements to gain

experience from the post-production activities. The output of this process can be used:

— as input into product realization;
— as input into risk management;
— for monitoring and maintaining product requirements;
— for communicating to regulatory authorities; or
— as input into improvement processes.

This document does not address market surveillance activities to be performed by regulatory

authorities. Neither does it specify a manufacturer’s actions required by the applicable regulatory

requirements resulting from their production or post-production activities, nor reporting to regulatory

authorities. This document is not intended to replace or change applicable regulatory requirements for

post-market surveillance.
2 Normative references
There are no normative references for this document.
3 Terms and definitions

For the purpose of this document, the definitions given in ISO 14971:2019 and ISO 13485:2016 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
post-market clinical follow-up study
PMCF-study

study carried out following marketing approval intended to answer specific questions relating to

clinical safety or performance (i.e. residual risks) of a medical device when used in accordance with its

approved labelling

Note 1 to entry: These may examine issues such as long-term performance, the appearance of clinical events

(such as delayed hypersensitivity reactions or thrombosis), events specific to defined patient populations, or the

performance of the medical device in a more representative population of providers and patients.

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[SOURCE: GHTF/SG5/N4: 2010, modified — "device" changed to "medical device"]

Note 2 to entry: For in-vitro diagnostics, a similar type of studies exists, e.g. post-market performance follow-up

(PMPF) study in Europe.
3.2
post-market surveillance

systematic process to collect and analyse experience gained from medical devices that have been placed

on the market
[SOURCE: ISO 13485:2016, 3.14]
4 Purpose of post-market surveillance process

In accordance with the requirements outlined in ISO 13485:2016 Clause 8 and ISO 14971:2019 Clause 10,

the organization documents one or more processes for collecting and analysing data from production

and post-production activities. This information can then be used as input into product realization,

risk management processes, determination of achievement of quality objectives or other actions for

improvement.

Post-market surveillance can also identify new opportunities for improvement associated with the

medical device in accordance with ISO 13485. It also provides the input to risk management process

in accordance to ISO 14971. Furthermore, it provides input into the design and development change

processes, in accordance to ISO 13485.
Post-market surveillance serves the following main purposes:

— Monitoring medical device safety and performance: Post-market surveillance links to other processes

established in the quality management system, including but not limited to feedback, analysis of

data, improvement, design and development processes, including design and development inputs,

risk management, clinical evaluation or performance evaluation. Post-market surveillance activities

help to ensure that available data are analysed and utilized to help make determinations about the

safety and performance of a medical device in accordance with the intended use.

— Meeting regulatory requirements: This document contains suggestions and techniques that can be

used to meet the applicable regulatory requirements. This can include analysing and reviewing

information to gain specific experience from production and post-production activities, trending

of processes and product, as well as feedback to the organisation for improvement activities, as

specified in the applicable regulatory requirements.

— Contributing to life cycle management: Post-market surveillance can also identify if the medical

device is not current state of the art based on the information from medical devices used for similar

purposes, the evolution to the state of the art, or alternative medical treatment procedures. These

signals can trigger a design modification, a change in intended use or purpose, a new medical device

design or removal of the medical device from the market. Post-market surveillance can generate

real world information that can be leveraged either to obtain new marketing authorizations for the

medical device (new markets, new indications supported by actual use of the medical device), or of

the next generation of medical device.

Figure 2 explains the position of post-market surveillance in the quality management system and its

relationship with the other processes.

NOTE Figure 2 is a more detailed representation of phases I and II from Figure 4 provided in the

ISO 13485:2016 Medical Device - A practical guide, Advice from ISO/TC210.
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Figure 2 — Example schematic representation of post-market surveillance
5 Planning of post-market surveillance
5.1 General

The post-market surveillance plan defines how the organization intends to actively collect and analyse

relevant data from the use of the medical device throughout the life cycle. Figure 2 outlines how the

post-market surveillance process interacts with other processes in a quality management system.

NOTE If a quality management system is not established, the same principles apply, although the processes

can be organized differently.
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ISO/TR 20416:2020(E)

The organization should ensure post-market surveillance activities are carried out in line with

documented methods and that the results of such activities are evaluated and reported to top

management.

The post-market surveillance activities should be planned before the first placing on the market of the

medical device and updated as necessary during product life cycle (see Clause 6).

A documented plan for post-market surveillance addresses the following:
— scope of the post-market surveillance plan (see 5.2);
— objective of the post-market surveillance plan (see 5.3);
— responsibilities and authorities (see 5.4);
— data collection (see 5.5);
— data analysis (see 5.6);
— report on data analysis (see 5.7);
— review of the post-market surveillance plan (see Clause 6).

The extent of post-market surveillance activities will depend upon several factors, such as the risks

associated with the medical device, the chosen data sources or the expected robustness of the available

information on safety and performance.

The post-market surveillance plan provides details on how the following clauses of this document

are addressed for the medical device or medical device family subject to the plan. The post-market

surveillance plan also addresses the methods used to collect and analyse available data in order to

provide information for other relevant processes.

The plan, as well as any data, information and reports generated according to the plan are considered

documents or records, see ISO 13485:2016 4.2.4 and 4.2.5.

An approved post-market surveillance plan should be contained within one or more documents

within the quality management system and may include references to other documents or procedures

containing post-market surveillance activities.

Post-market surveillance plans should consider input from a cross-functional team, see 5.4.

5.2 Scope of the post-market surveillance plan

The scope of the post-market surveillance plan depends on the type of the medical device. The following

non-exhaustive list of factors should be considered when defining the scope:
— the medical device type or medical device family, including accessories;
— regulatory classification;
— jurisdictions where the medical device is available;

— expected lifetime of the medical device, expected number of uses or usage frequency of the medical

device (single use vs. reusable instrument);
— the intended use;

— the available data related to safety and performance of the medical device, including clinical data;

— life cycle stage with regard to product and technology maturity in relation to state of the art.

By considering these examples and appropriately scoping the plan, the amount of resulting information

and data should be sufficient to confirm post-production safety and performance.
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5.3 Objective of the post-market surveillance plan

Regardless of the extent of design and development verification and validation activities, there will

always be some uncertainty about the safety and performance of the medical device during its life

cycle. The objectives of the post-market surveillance plan include reducing the identified uncertainty

by collecting and analysing new relevant information.

The post-market surveillance plan sets the objectives for the post-market surveillance activities in

relation with the medical device life cycle, the specification of the medical device, the intended use or

application and the applicable regulatory requirements in different markets. The plan should identify

the type and adequacy of information to be collected in order to satisfy the objectives. They can address

various aspects of the medical device, such as safety and performance including usability, labelling,

market adoption, user feedback and any other opportunities for improvement.

On defining the objectives of the post-market surveillance plan, the organization should specify the

associated measurable criteria, alert and action levels, as appropriate (see also 5.6).

The questions below can help formulate the objectives:

— Has any new hazard or hazardous situation been identified for the medical device or similar medical

devices or has the risk acceptability changed?
— Has any misuse of the medical device occurred?

— Does the medical device meet the user’s needs after medium/long term clinical use?

— Are there any unforeseen side effects for the medical device or similar medical devices?

— Are there any improvements that can be made to the medical device?

— Has state of the art changed after design and development of the medical device?

— Does the patient’s average age at medical device implantation, affect the medical device lifetime?

— Can user/patient training reduce the likelihood of malfunction?
— Is there a medical device malfunction that impacts the benefit-risk analysis?

— Are indications or contra-indications appropriate to ensure safety and effectiveness for the intended

use of the medical device?
— Do users experience any usability issues?
— Are recurring malfunctions due to service/maintenance deficiencies?

— Can significant increasing/decreasing trends be identified for a specific medical device malfunction

representing a possible source of harm?
— Is the expected lifetime correct?
— How does treatment affect the quality of life of the patient?

Table 1 and the example plans in Annex C provide more specific examples of objectives. The examples

given in Table 1 illustrate how some situations can lead to different objectives of a post-market

surveillance plan.
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Table 1 — Examples of post-market surveillance plan objectives.
Input process Situation Possible objectives post-market
surveillance plan

Design and development A new medical device that has just Monitor the safety and performance

been granted market approval. on a more frequent basis, than for
an established medical device for a
limited period of time as defined by
the organization.
Ensure that the links between the
clinical evaluation, pre-clinical stud-
ies and risk management processes
are robust and transparent.

Risk management Commercial launch of a surgical Continue to monitor the safety, per-

instrument specifically developed for formance and usability of the medi-
surgeons to perform the implanta- cal device to characterize the degree
tion of a medical device according to of satisfaction of the surgeons with
a break-through surgical technique. the medical device and their ability
The surgical instrument itself has a to reliably perform the surgical tech-
similar risk profile to other surgical nique using the surgical instrument.
instruments on the market.
Ensure that the links between the
clinical evaluation and risk man-
agement processes are robust and
transparent.

Clinical evaluation/ perfor- An implantable medical device for Obtain information on the long-term

mance evaluation which a clinical investigation was safety and performance of the medi-

performed to establish the short-term cal device, including clinical benefits,
safety and performance of the medi- which can be part of a PMCF-study.
cal device.
Confirm the prevalence of known or
See also ISO 14155: 2019 and suspected adverse events.
ISO 20916 (for in-vitro diagnostic
medical devices).

Regulatory Information from a user suggests that Invoke company feedback procedures

an existing medical device is being to further investigate this issue.
used for an indication not included in Collect data on the prevalence of
the instructions for use. the use and assess if current clinical
data supports the new usage. Other
actions can be considered necessary,
such as updating technical documen-
tation, evaluating the risk associated
with the new intended use.

Improvement Medical device already on the market Monitor continued satisfaction of the

for several years, in the maturity users with the medical device and
phase of its life cycle. the evolution of the state of the art.
Obtain feedback for improvement.,
not necessarily related to safety and
performance issues.

Marketing and sales An organization intends to market an Ensure appropriate usability data are

existing medical device for use in the being collected and that the medical
home environment in addition to the device is appropriate for home use
hospital. with the target patient population
before extending the intended use.
Consider new stakeholders as a
source of data, such as community
nurses and general practitioners.

Annex C contains several detailed examples of post-market surveillance activities for different types of

medical devices, including the objectives for these situations.
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5.4 Responsibilities and authorities

Top management should define, assign and communicate responsibilities and authorities for post-

market surveillance activities and should ensure the availability of resources with the independence

and competence for post-market surveillance activities. The post-market surveillance team should

include cross-functional representatives, for example resources from design and development, risk

management, quality assurance, complaint handling, returned medical device analysis, product

evaluation (clinical and performance), production, marketing and sales, regulatory, or service. It

should be noted, that the number of people involved largely depends on the size of the organization, the

complexity or perceived risk of the medical device and the responsibilities of each person.

The assignment of responsibilities and determination of required competence can be developed into a

resource allocation matrix, as shown in Table 2. The organization may choose to use external resources

(see also ISO 13485:2016, 4.1.5), provided those responsibilities are detailed in an appropriate written

quality agreement.
Table 2 — Example of post-market surveillance resources allocation matrix.
Post-market surveillance Responsible functions Competence
activity
Post-market surveillance plan Organization management The medical device and its
development and execution use, clinical/safety matters re-
lated to the medical device or
the organization’s post-mar-
ket surveillance process
Post-production incident Complaint handling Complaint handling and ad-
handling verse event reporting
Data analysis Statistics Quantitativ
...

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