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.
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