News about GMP/cGMP


EU: Implementing regulation on EUDAMED published

EU: Implementing regulation on EUDAMED published

On 26 November 2021, the European Commission issued the Implementing Regulation (EU) 2021/2078 on the European Database for Medical Devices, Eudamed. The document provides a legally binding framework for all users.

The regulation covers aspects such as registration for access, the collection of personal data or the procedure in case of malfunctions. The requirement for such  a document comes under EU MDR/IVDR, (EU) 2017/745 and (EU) 2017/746, which call for a definition of the modalities for the establishment and maintenance of Eudamed. Currently, Eudamed is only partially online, and the provision of the database is thus behind schedule.

Regulation (EU) 2021/2078) will enter into force 20 days after publication in the Official Journal of the European Commission.

Official Journal of the EU: Commission Implementing Regulation (EU) 2021/2078