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.
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.
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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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
po
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