CEN/TR 17223:2018

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

Leitfaden zum Zusammenhang zwischen EN ISO 13485: 2016 (Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke) und den europäischen Verordnungen über Medizinprodukte und In-vitro-Diagnostika

Document d’orientation sur la relation entre l’EN ISO 13485: 2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et le Règlement européen relatif aux dispositifs médicaux ainsi que le Règlement relatif aux dispositifs médicaux de diagnostic in vitro

Le présent Rapport technique fournit des recommandations relatives à la relation entre l’EN ISO 13485:2016 (Dispositifs médicaux — Systèmes de management de la qualité — Exigences à des fins réglementaires) et les exigences présentées dans le Règlement (UE) 2017/745 relatif aux dispositifs médicaux et au Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro.

Navodilo za povezavo med EN ISO 13485:2016 (Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene) ter Uredbo (EU) o medicinskih pripomočkih in Uredbo (EU) o in vitro diagnostičnih medicinskih pripomočkih

To tehnično poročilo vsebuje smernice glede razmerja med zahtevami v evropskih uredbah o medicinskih pripomočkih ter in-vitro diagnostičnih medicinskih pripomočkih in standardom EN ISO 13485:2016 - Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene.

General Information

• Status: Withdrawn
• Publication Date: 20-Mar-2018
• Withdrawal Date: 12-Sep-2023
• ICS: 03.100.70 - Management systems
• ICS: 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
• Ref Project: SIST-TP CEN/TR 17223:2018 - Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 17223:2018
01-maj-2018
1DYRGLOR]DSRYH]DYRPHG(1,620HGLFLQVNLSULSRPRþNL6LVWHPL
YRGHQMDNDNRYRVWL=DKWHYH]D]DNRQRGDMQHQDPHQHWHU8UHGER(8R
PHGLFLQVNLKSULSRPRþNLKLQ8UHGER(8RLQYLWURGLDJQRVWLþQLKPHGLFLQVNLK
SULSRPRþNLK
Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality
management systems - Requirements for regulatory purposes) and European Medical
Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Leitfaden zum Zusammenhang zwischen EN ISO 13485: 2016 (Medizinprodukte -
Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke) und den
europäischen Verordnungen über Medizinprodukte und In-vitro-Diagnostika
Document d’orientation sur la relation entre l’EN ISO 13485: 2016 (Dispositifs médicaux -
Systèmes de management de la qualité - Exigences à des fins réglementaires) et le
Règlement européen relatif aux dispositifs médicaux ainsi que le Règlement relatif aux
dispositifs médicaux de diagnostic in vitro
Ta slovenski standard je istoveten z: CEN/TR 17223:2018
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-TP CEN/TR 17223:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 17223:2018

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SIST-TP CEN/TR 17223:2018


TECHNICAL REPORT
CEN/TR 17223

RAPPORT TECHNIQUE

TECHNISCHER BERICHT
March 2018
ICS 03.100.70; 11.040.01

English version

Guidance on the relationship between EN ISO 13485: 2016
(Medical devices - Quality management systems -
Requirements for regulatory purposes) and European
Medical Devices Regulation and In Vitro Diagnostic
Medical Devices Regulation
Document d'orientation sur la relation entre l'EN ISO Leitfaden zum Zusammenhang zwischen EN ISO
13485: 2016 (Dispositifs médicaux - Systèmes de 13485: 2016 (Medizinprodukte -
management de la qualité - Exigences à des fins Qualitätsmanagementsysteme - Anforderungen für
réglementaires) et le Règlement européen relatif aux regulatorische Zwecke) und den europäischen
dispositifs médicaux ainsi que le Règlement relatif aux Verordnungen über Medizinprodukte und In-vitro-
dispositifs médicaux de diagnostic in vitro Diagnostika


This Technical Report was approved by CEN on 12 February 2018. 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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.





















CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2018 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. CEN/TR 17223:2018 E
reserved worldwide for CEN national Members and for
CENELEC Members.

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SIST-TP CEN/TR 17223:2018
CEN/TR 17223:2018 (E)
Contents Page
European Foreword . 3
Introduction . 4
1 Scope . 7
2 Normative references. 7
3 Terms and definitions . 7
4 Relationship between the European Regulations for Medical Devices and in vitro Diagnostic
Medical Devices and the clauses of EN ISO 13485 . 7

2

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SIST-TP CEN/TR 17223:2018
CEN/TR 17223:2018 (E)
European Foreword
This document (CEN/TR 17223:2018) has been prepared by Technical Committee CEN/CLC/JTC 3,
“Quality management and corresponding general aspects for medical devices”, the secretariat of
which is h
...