Publication of the list of harmonized standards for Medical Devices

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on harmonized standards for medical devices developed in support of Regulation (EU) 2017/745 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.