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.

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 European Commission establishes the regulatory framework (MDR and IVDR) that defines the requirements a device must meet to be CE marked, oversees the designation and monitoring of Notified Bodies, and coordinates national competent authorities across member states to ensure uniform enforcement.

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 (DG SANTE) is the branch of the European Commission directly responsible for medical device policy. The Commission is also responsible for creating expert panels to support scientific assessment and advice under the MDR and IVDR.
• The Medical Device Coordination Group (MDCG) is a key advisory body that publishes official guidance documents that manufacturers and Notified Bodies are expected to follow.
• 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 are the organizations that carry out conformity assessments and issue CE marking certificates. They operate under the oversight of their national competent authorities and are monitored by the Commission.

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