Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

The proposed Technical Report is to provide a common understanding of post-market surveillance, or
PMS facilitating international cooperation in this area. The Technical Report is intended for use by
manufacturers of medical devices. With PMS, the manufacturers can collect, evaluate, and analyze experience gained with their devices after placing on the market. The resulting information can be used for, among others, improvement of the devices.
The proposed Technical Report aims to describe a comprehensive data collection process and activities that allow characterization of the behavior of the devices as used in practice, and identify necessary and/or possible actions. PMS information may include material that requires reporting to Regulatory Authorities. The proposed Technical Report will not provide information for such reporting, nor for achieving compliance with any other (PMS) requirement by Regulatory Authorities.
Market surveillance by national authorities, as well as actions legally required to be performed by manufacturers as part of PMS or vigilance are outside the scope of the proposed Technical Report. The document is not intended to replace or change national or regional legislation on PMS.

Medizinprodukte - Überwachung nach dem Inverkehrbringen (ISO/TR 20416:2020)

Dispositifs médicaux - Surveillance après mise sur le marché incombant aux fabricants (ISO/TR 20416:2020)

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.

Medicinski pripomočki - Nadzor proizvajalcev po dajanju v promet (ISO/TR 20416:2020)

General Information

Status
Published
Public Enquiry End Date
14-Apr-2020
Publication Date
13-Sep-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Sep-2020
Due Date
06-Nov-2020
Completion Date
14-Sep-2020

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SLOVENSKI STANDARD
SIST-TP CEN ISO/TR 20416:2020
01-oktober-2020
Medicinski pripomočki - Nadzor proizvajalcev po dajanju v promet (ISO/TR
20416:2020)
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Medizinprodukte - Überwachung nach dem Inverkehrbringen (ISO/TR 20416:2020)

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

(ISO/TR 20416:2020)
Ta slovenski standard je istoveten z: CEN ISO/TR 20416:2020
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST-TP CEN ISO/TR 20416:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN ISO/TR 20416:2020
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SIST-TP CEN ISO/TR 20416:2020
TECHNICAL REPORT
CEN ISO/TR 20416
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
August 2020
ICS 11.040.01
English version
Medical devices - Post-market surveillance for
manufacturers (ISO/TR 20416:2020)

Dispositifs médicaux - Surveillance après mise sur le Medizinprodukte - Überwachung nach dem

marché incombant aux fabricants (ISO/TR Inverkehrbringen (ISO/TR 20416:2020)
20416:2020)

This Technical Report was approved by CEN on 7 June 2020. It has been drawn up by the Technical Committee CEN/CLC/JTC 3.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,

Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,

Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,

Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels

© 2020 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. CEN ISO/TR 20416:2020 E

reserved worldwide for CEN national Members and for
CENELEC Members.
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SIST-TP CEN ISO/TR 20416:2020
CEN ISO/TR 20416:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST-TP CEN ISO/TR 20416:2020
CEN ISO/TR 20416:2020 (E)
European foreword

This document (CEN ISO/TR 20416:2020) has been prepared by Technical Committee ISO/TC 210

"Quality management and corresponding general aspects for medical devices" in collaboration with

Technical Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for

medical devices” the secretariat of which is held by NEN.

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

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of ISO/TR 20416:2020 has been approved by CEN as CEN ISO/TR 20416:2020 without any

modification.
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SIST-TP CEN ISO/TR 20416:2020
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SIST-TP CEN ISO/TR 20416:2020
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
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SIST-TP CEN ISO/TR 20416:2020
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
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SIST-TP CEN ISO/TR 20416:2020
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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SIST-TP CEN ISO/TR 20416:2020
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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SIST-TP CEN ISO/TR 20416:2020
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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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SIST-TP CEN ISO/TR 20416:2020
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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SIST-TP CEN ISO/TR 20416:2020
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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SIST-TP CEN ISO/TR 20416:2020
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 evaluatio
...

SLOVENSKI STANDARD
kSIST-TP FprCEN ISO/TR 20416:2020
01-april-2020
Medicinski pripomočki - Nadzor proizvajalcev po dajanju v promet (ISO/PRF TR
20416:2020)

Medical devices - Post-market surveillance for manufacturers (ISO/PRF TR 20416:2020)

Ta slovenski standard je istoveten z: FprCEN ISO/TR 20416
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
kSIST-TP FprCEN ISO/TR 20416:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST-TP FprCEN ISO/TR 20416:2020
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kSIST-TP FprCEN ISO/TR 20416:2020
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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kSIST-TP FprCEN ISO/TR 20416:2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
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kSIST-TP FprCEN ISO/TR 20416:2020
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

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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.
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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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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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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 an
...

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