Harmonized European Standards under the European Regulations on MD and IVD MD

On May 12, 2021, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) formally informed the European Commission that they had accepted the standardization request of April 14, 2021. The purpose of the request is the revision of existing harmonized standards in order to establish the list of harmonized standards with presumption of conformity to the requirements of Regulation (EU) 2017/745 on medical devices and the requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

The work to identify the relevant harmonized standards is underway and publications could take place as early as June 2021.

For more information: https://ec.europa.eu/health/md_topics-interest/overview

DOWNLOAD : COMMISSION IMPLEMING DECISION OF APRIL 14 2021