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.

For medical devices, the Directorate-General for Health and Food Safety (DG SANTE) leads Commission policy and supports implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The Commission develops implementing measures, manages EU-level systems such as EUDAMED, coordinates with Member States, and chairs the Medical Device Coordination Group (MDCG). The MDCG is established by the MDR and consists of Member State representatives; it is not an internal division of DG SANTE. National competent authorities retain primary responsibility for enforcement, vigilance, and market surveillance in their jurisdictions.

When was the European Commission established?

The EC originated in 1951 as the High Authority under the Treaty of Paris. It evolved under various treaties until the Treaty on European Union in 1993, when it became known as the European Commission.

Which countries are in the European Commission?

The European Commission comprises individual commissioners from each EU member state. The EU has 27 member states, meaning there are 27 commissioners, each nominated by their home country's government. The 27 EU member states represented in the European Commission are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden.

Does the European Commission issue CE Marking certificates?

No, the European Commission does not issue CE Marking certificates directly. For medical devices, CE Marking certificates are issued by Notified Bodies, which are independent, third-party organizations (e.g., BSI (UK/EU), TÜV SÜD, TÜV Rheinland, and SGS) that have been officially designated by EU member state authorities to conduct conformity assessments.

The MDR and IVDR establish the regulatory framework for CE marking. Member States designate and monitor Notified Bodies, while the Commission participates in coordination and joint-assessment mechanisms. National competent authorities enforce the rules and conduct market surveillance within their jurisdictions.

Who oversees medical device regulation within the European Commission's framework?

Medical device regulation in the EU is a shared responsibility across several institutions:

• The European Commission, principally through DG SANTE, leads EU-level medical device policy, implementing measures, coordination, EUDAMED, and expert-panel arrangements under the MDR and IVDR.
• The Medical Device Coordination Group (MDCG) consists of representatives appointed by Member States and is chaired by the Commission. It develops non-binding guidance to support consistent implementation.
• The European Medicines Agency (EMA) monitors the safety and efficacy of medicines in the EU, which extends to combination products (medical devices that incorporate a medicinal substance).
• National Competent Authorities (NCAs) in each Member State are responsible for market surveillance, vigilance reporting, and oversight of Notified Bodies within their jurisdiction.
• Notified Bodies carry out conformity assessments and issue certificates within their designated scope. They operate under the oversight of their national designating authorities, with EU-level coordination and joint assessments involving the Commission and Member States.

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