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EN ISO 13485:2016/A11:2021

(Amendment)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)

Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO 13485:2016)

Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene - Dopolnilo A11 (ISO 13485:2016)

General Information

Status
Published
Publication Date
07-Sep-2021
Withdrawal Date
30-Mar-2022
ICS
03.100.70 - Management systems
11.040.01 - Medical equipment in general
Technical Committee
CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
Drafting Committee
CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
08-Sep-2021
Due Date
02-Oct-2021
Completion Date
08-Sep-2021
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
M/MDR - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
Ref Project
SIST EN ISO 13485:2016/A11:2021 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Relations

Amends
EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Effective Date
08-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 13485:2016/A11:2021
01-december-2021
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne
namene - Dopolnilo A1 (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO 13485:2016)
Ta slovenski standard je istoveten z: EN ISO 13485:2016/A11:2021
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
SIST EN ISO 13485:2016/A11:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13485:2016/A11:2021

---------------------- Page: 2 ----------------------
SIST EN ISO 13485:2016/A11:2021


EUROPEAN STANDARD
EN ISO 13485:2016/A11

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2021
ICS 03.100.70; 11.040.01

English version

Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la Medizinprodukte - Qualitätsmanagementsysteme -
qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO
13485:2016) 13485:2016)
This amendment A11 modifies the European Standard EN ISO 13485:2016; it was approved by CEN on 12 April 2021.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 13485:2016/A11:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/745 aimed to be covered . 4
Annex ZB (informative)  Relationship between this European standard and the
requirements of Regulation (EU) 2017/746 aimed to be covered . 16

2

---------------------- Page: 4 ----------------------
SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
European foreword
This document (EN ISO 13485:2016/A11:2021) has been prepared by Technical Committee
CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
This document amends EN ISO 13485:2016, incorporating corrigenda March 2016, December 2016 and
2018, with a revised European Foreword and European Annexes ZA and ZB.
This Amendment to the European Standard EN ISO 13485:2016 has been prepared under a mandate
given to CEN by the European Commission and the European Free Trade Association, and supports
requirements of EU Regulation(s).
For relationship with EU Regulation(s), see informative Annex ZA, and ZB, which are an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the referenced
...

SLOVENSKI STANDARD
SIST EN ISO 13485:2016/A11:2021
01-december-2021
Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne
namene - Dopolnilo A11 (ISO 13485:2016)
Medical devices - Quality management systems - Requirements for regulatory purposes
(ISO 13485:2016)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische
Zwecke (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins
réglementaires (ISO 13485:2016)
Ta slovenski standard je istoveten z: EN ISO 13485:2016/A11:2021
ICS:
03.100.70 Sistemi vodenja Management systems
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
SIST EN ISO 13485:2016/A11:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 13485:2016/A11:2021

---------------------- Page: 2 ----------------------
SIST EN ISO 13485:2016/A11:2021


EUROPEAN STANDARD
EN ISO 13485:2016/A11

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2021
ICS 03.100.70; 11.040.01

English version

Medical devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016)
Dispositifs médicaux - Systèmes de management de la Medizinprodukte - Qualitätsmanagementsysteme -
qualité - Exigences à des fins réglementaires (ISO Anforderungen für regulatorische Zwecke (ISO
13485:2016) 13485:2016)
This amendment A11 modifies the European Standard EN ISO 13485:2016; it was approved by CEN on 12 April 2021.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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
© 2021 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 13485:2016/A11:2021 E
reserved worldwide for CEN national Members and for
CENELEC Members.

---------------------- Page: 3 ----------------------
SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the
requirements of Regulation (EU) 2017/745 aimed to be covered . 4
Annex ZB (informative)  Relationship between this European standard and the
requirements of Regulation (EU) 2017/746 aimed to be covered . 16

2

---------------------- Page: 4 ----------------------
SIST EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/A11:2021
European foreword
This document (EN ISO 13485:2016/A11:2021) has been prepared by Technical Committee
CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the
secretariat of which is held by NEN.
This document amends EN ISO 13485:2016, incorporating corrigenda March 2016, December 2016 and
2018, with a revised European Foreword and European Annexes ZA and ZB.
This Amendment to the European Standard EN ISO 13485:2016 has been prepared under a mandate
given to CEN by the European Commission and the European Free Trade Association, and supports
requirements of EU Regulation(s).
For relationship with EU Regulation(s), see informative Annex ZA, and ZB, which are an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
The following referenced documents are indispensable for the application of this document. For undated
references, the edition of the reference
...

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Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

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