CEN ISO/TR 20416:2020
(Main)Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
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.
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
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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© 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.
Contents Page
European foreword . 3
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.
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
ISO/TR 20416:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2020 – All rights reserved
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/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
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/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
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/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
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/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
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/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
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
collected data
Ongoing clinical data Clinical and medical affairs Clinical evaluation methodol-
collection ogies, defined clinical circum-
stances and pathologies
Literature search Information and medical Data mining processes and
affairs services methodologies, literature
searches and defined clinical
circumstances and patholo-
gies
Production data collection Production Manufacturing methodologies
and production non-conform-
ance processes
External expert opinion External healthcare Use and usability of medical
professionals and devices in the clinical setting
end-users
Medical device in use Sales and marketing Use and usability of medical
devices, including clinical
setting
Post-market surveillance All defined functions Functional areas and activi-
plan and report review and responsible for activities ties under responsibility
approval
5.5 Data collection
5.5.1 Data sources
It is the responsibility of the organization to determine and document the sources of post-market
surveillance data. The data sources should be appropriate and reliable enough to give information
relevant to the specified objectives within the post-market surveillance plan. When selecting
ISO/TR 20416:2020(E)
data sources, the different categories of parties involved (e.g. distributors, importers, healthcare
professionals and patients) and the situation in which the medical devices are used are considered. Data
quality and integrity should be considered before analysing data to ensure the information is reliable.
For example, the use of unverifiable data can lead to over-reaction, as it can be based on non-scientific
data sources such as social media and public media. Therefore, appraisal of data and its sources is
recommended as part of the post-market surveillance plan.
The collection of data is a combination of both proactive and reactive activities. The data collected
should be proportionate to the risk of and the experience with the medical device, its intended use and
related technology, to facilitate early identification of safety and performance issues. Annex A contains
a non-exhaustive list of examples of data sources that can be considered. Note that some sources
might not be needed to fulfil the objectives. In addition, Annex B of GHTF/SG3/N18 contains additional
guidance on specific data sources.
5.5.2 Defining data collection methods
After selecting the data sources, the method for collecting the data from these sources should be
established. In some cases, the name of the source already encompasses the data collection method.
There are several common methods of data collection, that can be divided into proactive and reactive
methods. Examples include, but are not limited to:
Proactive:
— written or electronic surveys or questionnaires;
— interviews of users;
— literature search;
— use of medical device registries;
— post-market clinical follow-up studies (or post-market performance follow-up studies, IVDs);
— recall information and other information released from regulatory agencies.
Reactive:
— review of complaints (including incident reports);
— review of non-solicited observations by healthcare professionals or observations by the
organization’s sales and marketing team members;
— review of service reports or maintenance reports;
— review of regulatory compliance notifications.
For the selection of the appropriate data collection methods, the organization should consider the
following characteristics:
— the analysis method, e.g. qualitative or quantitative (statistical), descriptive, transcription,
codification (see 5.6);
— sample size, depending on medical device usage;
— the goal of the method, e.g. to establish cause, explore ideas, to identify what or where things happen.
The time span for which data are collected is established by the organization and should be in line with
the objective of the post-market surveillance plan. The information to be collected in this time span
should be applicable to the medical device and its intended use for which the post-market surveillance
is performed. For example, when considering historical data, the organization would ensure that the
time span is appropriate with the state of the art. Time spans can be specific to each data source and
should be such that sufficient relevant data can be collected.
8 © ISO 2020 – All rights reserved
ISO/TR 20416:2020(E)
5.5.3 Developing the data collection protocol
After documenting the method(s) of data collection (note that this can be a combination of more than one
method, depending on the nature of the medical device), the next step is to develop the data collection
protocol. The protocol should describe all steps required, to ensure consistency of the collected data.
Consideration should be given to the advantages or disadvantages of the method that has been chosen.
Data collection protocols can be included in other documents, such as a post-market clinical follow-up
study plan.
Important aspects that should be considered when developing the protocol are:
— how data collection is completed and managed;
— how data are recorded and by whom;
— how data are monitored and possibly updated;
— how to ensure data integrity and quality; or
— who is responsible for data integrity and quality.
5.6 Data analysis
5.6.1 General
This subclause provides guidance about choosing an appropriate method for data analysis, and outlines
some of the more common methods which can be used. However, it does not, exclude other methods.
There are many different data analysis methods including quantitative techniques, each having their
own advantages or limitations. The possibilities range from qualitative data analysis or descriptive
graphical methods (e.g. histograms or trending charts) to sophisticated quantitative evaluations using
formal charting including statistical process control methods. Selection of the appropriate type of
analysis depends on the objective and the underlying data for the analysis.
The quality of the data is essential to the selection of the appropriate methods due to the assumptions
associated with the technique. The choice of statistical methods depends upon the data distribution,
e.g. normal distribution vs Poisson distribution.
The method used for data analysis should be defined as part of the post-market surveillance plan prior
to the start of data collection, to ensure that the results meet the objectives (see 5.3) of the analysis.
5.6.2 Considerations concerning planning the data analysis
As the types of medical devices and the patient populations can be different, various methods of
analysing the data can be required. It should be determined, which parameters are analysed and
what are the respective reference values (e.g. batches, sub-batches, total number of medical devices
manufactured, hours/frequency of use, number of medical devices in-use, patient populations, if
more than one exists). As an example, the down time (parameter) of an electric medical device can be
compared with its hours of use (reference value). The rationale for the choice of the methods for data
analysis should be documented.
The data analysis time span is established by the organization in line with the objective. The time span
during which the data are analysed should be proportionate to the risk associated with the medical
device and dependent upon the quantity and type of post-market surveillance data needed for the
analysis.
5.6.3 Methods for data analysis
The method of analysis to be used depends on the type of the collected raw data. For example, customer
communication including complaints is analysed differently than reports in a scientific publication,
ISO/TR 20416:2020(E)
and input from a public congress or media/press publication is analysed differently from the result of
testing using international standards.
The format for the requested result of the analysis, as appropriate for post-market surveillance, is also
a point for consideration. Examples of the objective and appropriate data analysis methods are given in
Table 3.
Table 3 — Examples of the objective and appropriate data analysis methods
Objective One possible example for methods
Monitoring medical device safety and performance Trend analysis by charting data of the same attribute
over a specified period. The analysis of patterns can
follow the rules of the statistical process control (SPC).
Meeting regulatory requirements Non-statistical (qualitative) analysis by document
review (e.g. regulations, standards).
Contributing to life cycle management Pareto analysis to rank the occurrence of specific
attributes (e.g. defects), see also B.5.
The main distinction between data analysis methods is based on the ability to use quantitative or
qualitative data.
Common quantitative methods include, but are not limited to:
— descriptive statistics (e.g. mean, median, mode, percentage, frequency, range);
— inferential statistics (e.g. correlation, regression, analysis of variance).
Common qualitative methods include, but are not limited to:
— content analysis;
— narrative analysis;
— discourse analysis;
— grounded theory.
Semi-quantitative methods include both features of a quantitative and qualitative method.
Data sources such as complaints can be analysed through quantitative methods, but a preliminary
qualitative analysis could be necessary in order to be able to extract quantitative data. Data retrieved
from peer-reviewed scientific literature can be analysed combining quantitative and qualitative
methods. An example of quantitative analysis of data retrieved from peer-reviewed scientific literature
is a meta-analysis of published clinical studies.
A non-exhaustive list of examples of data analysis methods and a short description on how to use them
can be found in Annex B.
Any concerns regarding data reliability and the representative nature of that data as it relates to the
market should be documented.
5.7 Report on data analysis
The report or summary should summarize all results and conclusions generated after implementation
of the post-market surveillance plan. A possible list of contents could include, but is not limited to:
— summary: including report identification information and organization information;
— background information on the medical device: medical device identification information, short
description of the medical device and commercial information, expected lifetime of the medical device;
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ISO/TR 20416:2020(E)
— overview of gathered post-market surveillance data;
— analysis and evaluation of reported data;
— recommendations for actions to be taken;
— conclusions on benefit-risk determination.
The report should b
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