List of Harmonized Standards for Quality Management Systems, Sterilisation and the Application of Risk Management to Medical Devices Has Been Updated -published on Product Compliance Manager - May 17, 2022.

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Commission Implementing Decision (EU) 2022/757 of May 11, 2022

The European Commission has recently made updates to the Implementing Decision (EU) 2021/1182. 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) 2021/1182? We recommend you check the new list of standards to see if any of the standards you applied have been updated. 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.

Our post on Product Compliance Manager outlines the changes for your convenience. This publication is only available to subscribers. Feel free to subscribe, it is at no cost.