On November 29th, 2021, the European Commission published in the Official Journal the commission implementing regulation (EU) 2021/2078 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (EUDAMED).

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union and covers access modes, the functioning rules, the measures to prevent any malfunction, IT security, …

 

DOWNLOAD THE COMMISSION IMPLEMENTING REGULATION (EU) 2021/2078

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