List of Standards for QMS and for Application of Risk Management to Medical Devices Updated
List of Standards for Quality Management Systems and for Application of Risk Management to Medical Devices Updated -published on Product Compliance Manager - May 13, 2022
Commission Implementing Decision (EU) 2022/729 - May 11, 2022
The European Commission has recently made updates to the Implementing Decision (EU) 2021/1195. In effect, this updated list is important to all manufacturers of CE marked products that have used European harmonized standards to prove CE compliance according to these regulations.
Do you have applied standards to prove compliance in regard to the Implementing Decision (EU) 2021/1195? In that case we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.
In comparison with the previous Implementing Decision ((EU) 2021/1195), there are two alterations in the Annex.
First of all, entry number 7 is replaced by the following:
- 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’;
Furthermore, a new entry is added to the Annex, entry number 10:
- EN ISO 14971:2019
- Medical devices – Application of risk management to medical devices (ISO 14971:2019)
- EN ISO 14971:2019/A11:2021’.
Links and Downloads
Other, related articles, that may be of your interest:
- Amendments List of Standards Machinery Directive 2006/42/EC
- Amendments List of Standards EMC Directive (2014/30/EU)