Implementing Regulation (EU) 2021/2078

Are you a manufacturer, authorised representative or importer of a medical device? If so, you will soon (most likely in May 2022) need to register information about yourself, your company and the medical device in EUDAMED. EUDAMED is the ‘European Database on Medical Devices’.

Pending the commissioning of EUDAMED, the European Commission adopted Implementing Regulation 2021/2078 in November 2021. In this regulation, which entered into force in December 2021, the Commission has set out the rules necessary for the establishment, access, maintenance and security of EUDAMED.

You can find more information about EUDAMED in our library.