Publication of the list of harmonized standards for in vitro Medical Devices

Publication of the list of harmonized standards for in vitro Medical Devices

Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on harmonized standards for in vitro diagnostic medical devices developed in support of Regulation (EU) 2017/746 has been published.

You should then check whether these standards apply to your in vitro diagnostic medical devices or quality management system activities. If so, you must implement them as evidence of compliance with the conformity assessment procedures.

Count on us to help you implement these activities.