The European Commission supports EU countries, which have public safety and healthcare amongst its main responsibilities. This support is provided through various dialogue formats and interlocutors.
What the Commission does
The Directorate-General for Health and Food Safety encourages dialogue on medical devices. This includes
- responding to written questions on medical devices from Members of the European Parliament
- maintaining a permanent dialogue with national competent authorities, Medical Device Coordination Group (MDCG), Competent Authorities for Medical Devices (CAMD) and stakeholders, including professional organisations, patients’ and medical practitioners’ organisations, standardisation bodies and notified bodies
- supporting a wide range of working groups who identify and solve issues around the application of EU law
- consulting the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) and the Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) when a scientific issue is raised
- launching public consultations on major policy issues
- cooperating with a number of policy and regulatory dialogues at international level
Medical Device Coordination Group - MDCG
The Medical Device Coordination Group (MDCG) is an expert group. It was established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Its members are experts representing competent authorities of the EU countries.
The MDCG advises and assists the Commission and EU countries in the implementation of both Regulations. The MDCG operates in accordance with the horizontal rules on the creation and operation of Commission expert groups. It is listed in the Register of Commission Expert Groups and Other Similar Entities under the code X03565.
The MDCG has 13 subgroups.
Competent Authorities for Medical Devices - CAMD
The Competent Authorities for Medical Devices (CAMD) facilitates implementing and enforcing the Regulations on medical devices and on In Vitro Diagnostic medical devices.
The CAMD also provides training and exchange of best practices.
Its meetings are also networking events and may tackle medical device issues beyond the MDR and IVDR.
Notified Body Coordination Group - NBCG-Med
- A coordination group of notified bodies in the field of medical devices is established in accordance with Article 49 of Regulation (EU) 2017/745 on medical devices and Article 45 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
- All notified bodies designated under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices participate in the work of the group.
- The Notified Body Coordination Group - NBCG-Med
- Allows notified bodies to share experience and exchange views on the application of conformity assessment procedures and the activities of notified bodies
- Promotes consistency among notified bodies and their processes
- Drafts technical recommendations and creates consensus on matters relating to conformity assessment and the activities of notified bodies
- Advises the Commission and the MDCG, at its request, on medical device legislation and its implementation
- NBCG-Med has a technical subgroup, Notified Body Technical Group, divided into a section for medical devices topics (NBTG-MD) and a section for in vitro diagnostic topics (NBTG-IVD).
Template for notified body confirmation letter of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607