Medical Device Coordination Group (MDCG)

What is the Medical Device Coordination Group (MDCG)? The Medical Device Coordination Group (MDCG) is an expert advisory body established under the EU’s Medical Device Regulation (MDR, Regulation (EU) 2017/745) and In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746). It comprises representatives appointed by each EU Member State’s competent authority, alongside a chair appointed by the European Commission. The MDCG serves to assist and counsel both the Commission and Member States in implementing and interpreting these regulations in a harmonized manner. What does the MDCG do? The MDCG plays a central role in shaping the consistent and effective application of EU medical device legislation. It produces non-binding yet widely respected guidance documents covering critical domains—such as device classification, borderline determinations, post-market surveillance, clinical evaluation, e‑health technologies, nomenclature, and EUDAMED support—to clarify regulatory requirements and support compliance. To maintain technical depth and agility, the MDCG delegates tasks to thirteen specialized subgroups—each chaired by the Commission—focused on topics ranging from new technologies and UDI systems to market surveillance and notified body coordination. These working groups develop terms of reference, draft guidance, and help refine interpretive clarity for stakeholders. The MDCG also advises on the designation and oversight of notified bodies, contributes to the implementation of surveillance programs, and may request scientific opinions through expert panels when device safety concerns arise. Though its outputs are not legally binding, they are often treated by authorities and manufacturers as “state of the art” references for regulatory compliance.