EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021

General information

Current stage: 60.60 Standard published Sep 8, 2021

Originator: CEN/CENELEC

Owner: CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

Type: European Norm

ICS: 03.100.70 Management systems | 11.040.01 Medical equipment in general

Related legislation

Legislation related to this standard

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

Harmonized/Supporting

Legislation 2017/745

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

Harmonized/Supporting

Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 13485:2016

NOW

PUBLISHED
EN ISO 13485:2016/A11:2021
60.60 Standard published
Sep 8, 2021