Medical Device Coordination Group (MDCG) in the context of clinical studies of medical devices

The Medical Device Coordination Group (MDCG) is an important group of experts in the field of medical device regulation in the European Union.

Why does the MDCG exist and what is its composition?

The MDCG is an expert group required by the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). It consists of representatives from all EU Member States and is chaired by a representative of the European Commission.

Tasks and functions of the MDCG

The MDCG mainly has consultation and coordination functions:

• It consults the European Commission in various areas of medical device regulation.
• It draws up a market surveillance programme for the competent authorities.
• It can request scientific opinions on products in the event of safety concerns.
• It deals with important issues in the medical device sector, from the supervision of notified bodies to market surveillance and clinical investigations.

Structure and working methods

• The MDCG is divided into 13 subgroups, each of which specialises in a particular field.
• These subgroups develop guidelines and provide consultation in their respective areas of specialisation.
• The members of the subgroups are appointed by the member states for three years.

Significance for the industry

The work of the MDCG has a direct impact on notified bodies, medical device manufacturers and their service providers:

• It provides recommendations on the applicability of the MDR and IVDR to specific products.
• It influences the requirements for audits and technical documentation.
• It is consulted on the creation of new common specifications.
• It publishes guidelines for the design, planning and conduct of clinical studies and performance studies, which are published at regular intervals.

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The MDCG therefore plays a central role in the implementation and interpretation of EU medical device regulations and has a significant influence on the regulatory landscape in the medical device sector.

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