General introduction
In accordance with the Clinical Trials Regulation (EU) 536/2014 (CTR) Article 4, ‘A clinical trial shall be subject to scientific and ethical review and shall be authorised in accordance with this Regulation’ and that ‘The ethical review shall be performed by an ethics committee in accordance with the law of the Member State concerned.’
The Ethics Committee is empowered to review and give opinions on clinical trials application prior to their authorisation in line with the Clinical Trials Regulation and the national law of the respective Member State where appropriate.
MedEthicsEU is a group of national representatives of medical research ethics committees (MRECs) that was created in February 2024 to provide a forum for discussion and mutual learning between EU/EEA Member States Ethics Committees. This allows enhanced cooperation between Member States’ Ethics Committees and further supports harmonisation in the ethics review of clinical trials in Europe.
The Ethics Committees of each EU/EEA Member State are independent bodies. One to two regulatory experts are nominated as national representatives of their MRECs in MedEthicsEU.
Mandate of the group
The group aims at strengthening collaboration between the MRECs across Member States reviewing:
- Clinical trials applications falling under the Clinical Trials Regulation (EU) 536/2014 (CTR)
- Performance study applications falling under the In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) and
- Clinical investigation applications falling under Medical Device Regulation (EU) 2017/745 (MDR) in the EU/EEA MS.
MedEthicsEU endeavours to deliver on the following tasks and objectives:
- To provide a forum for discussion between MRECs on differences related to structures, work procedures and positions of MRECs across Member States;
- To align and promote harmonisation on operational procedures of MRECs in compliance with ethics standards;
- To establish cooperation related to research ethics matters with relevant European level entities in the field of clinical research, in particular:
- CTAG (Clinical Trials Coordination and Advisory Group established by the CTR)
- the European Medicines Agency (EMA),
- the Clinical Investigation subgroup (CIE) and
- the In Vitro Diagnostics subgroup (IVD) of the Medical Device Coordination Group (MDCG);
- To cooperate with CTCG (Clinical Trials Coordination Group of Heads of Medicines Agencies).
- Rules of procedure of MedEthicsEU
In addition to the above, the board of MedEthicsEU holds regular meetings with the board of European Network of Research Ethics Committees (EUREC) to ensure alignment of ethics processes across Europe.
Membership
All Member States are encouraged to have 1 to 2 representatives in the group. These representatives can be members of a medical research ethics committee or members of the secretariat supporting the medical research ethics committees at national level. National contact points of the Clinical Trials Coordination and Advisory Group (CTAG) have nominated representatives from their respective Member State.
Deliverables
MedEthicsEU has updated the report on their survey on national Part II Clinical Trial Application (CTA) requirements (March 2025), to which 19 Member States have contributed.
Eudralex Volume 10 on Clinical Trial Guidelines
EudraLex - Volume 10 - European Commission (europa.eu)
Meeting agenda and minutes
- 15 February 2024, (Kick-off Meeting) Minutes and Agenda will soon be available here
