European Commission

The European Commission (EC) serves as the European Union’s independent executive branch. It is the sole institution with the authority to propose new laws and regulations, manage the day-to-day administration of policies, and enforce treaties, to ensure member states implement EU legislation. The Commission includes a President and one commissioner from each member state, appointed through a process involving the European Council and Parliament.

In terms of medical device oversight, the Directorate-General for Health and Food Safety (DG SANTE) is the division within the Commission that developed and enforces Regulations (EU) 2017/745 (MDR) on medical devices and 2017/746 (IVDR) on in vitro diagnostic devices, which became applicable in 2021 and 2022, respectively. Under the MDR and IVDR, foreign and EU-based medical device and IVD companies must demonstrate their product's conformity with General Safety and Performance Requirements (GSPRs) according to the device's risk classification and obtain CE Marking, the certification symbol required to legally sell medical devices and other regulated products in the EU. The DG SANTE also includes the Medical Device Coordination Group (MDCG) and EUDAMED, an integrated IT system and database of information about devices distributed on the EU market.

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Website: European Commission
Address: European Commission, 1049 Bruxelles/Brussel, Belgium
Phone: +32 2 299 11 11
Email: Contact form