European Commission

What is the European Commission? The European Commission serves as the European Union’s independent executive branch. It is the sole institution empowered to propose new EU laws, manage the day-to-day administration of EU policies, and act as the guardian of EU treaties—ensuring that member states faithfully implement EU legislation. The Commission comprises a President and one commissioner from each member state, appointed through a process involving the European Council and European Parliament. What does the European Commission do? The Commission oversees and harmonizes regulatory frameworks across member states. In the realm of medical devices, it developed and enforces Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), which set new standards for device safety, performance, and transparency. It also created EUDAMED, an integrated IT system to support regulation and monitoring of device compliance and market activity. The Commission facilitates stakeholder consultation and evidence-based lawmaking through its “better regulation” agenda, prioritizing open, transparent, and proportionate policy design.