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

Status
Published
Publication Date
18-Aug-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-Aug-2020
Due Date
08-Aug-2019
Completion Date
19-Aug-2020

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Standards Content (Sample)

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

2

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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.


3

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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 .
...

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.

---------------------- Page: 1 ----------------------
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

---------------------- Page: 3 ----------------------
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.
...

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