Glossary Term
Medical Device Coordination Group (MDCG)
Definition
The Medical Device Coordination Group (MDCG) is an expert advisory body established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Comprising representatives from the competent authorities of EU member states, the MDCG assists the European Commission and member states in implementing and harmonizing these regulations.
Relevance to the MedTech Industry
The MDCG ensures a standardized approach is taken to the regulation of medical technologies.
Additional Information & Related Terms
Key Functions of the MDCG:
Guidance Development: The MDCG issues guidance documents to clarify regulatory requirements, aiding stakeholders in complying with the MDR and IVDR. These documents cover various topics, including device classification, clinical evaluation, and post-market surveillance.
Coordination and Oversight: The group coordinates activities among member states to ensure consistent application of medical device regulations across the EU. It also oversees the designation and monitoring of notified bodies responsible for conformity assessments.
Working Groups: The MDCG operates through specialized subgroups focusing on specific areas such as market surveillance, new technologies, and in vitro diagnostic devices. These subgroups provide detailed expertise and develop targeted guidance.
By facilitating collaboration among EU member states and providing clear guidance, the MDCG plays a crucial role in ensuring the safety, performance, and compliance of medical devices within the European Union.