Commission Implementing Decision (EU) 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for quality management systems and for application of risk management to medical devices

• CELEX: Implementing Decision (EU) 2022/729
• Articles: 3

Article 1

The Annex to Implementing Decision (EU) 2021/1195 is amended in accordance with the Annex to this Decision.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .

Point 1 of the Annex shall apply from 7 January 2022.

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Decision (EU) 2021/1195 is amended as follows:

(1)

entry No 7 is replaced by the following:

No

Reference of the standard

‘7.

EN ISO 13485:2016

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

EN ISO 13485:2016/AC:2018

EN ISO 13485:2016/A11:2021’;

(2)

the following entry is added:

No

Reference of the standard

‘10.

EN ISO 14971:2019

Medical devices – Application of risk management to medical devices (ISO 14971:2019)

EN ISO 14971:2019/A11:2021’.