Article 1
The Annex to Implementing Decision (EU) 2021/1195 is amended in accordance with the Annex to this Decision.
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
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
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
Supplementary provisions
ANNEXSupplementary provisions
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’.
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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