Medical Device Coordination Group (MDCG)

The Medical Device Coordination Group (MDCG) is an expert advisory body established under the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) and In Vitro Diagnostic Regulation (IVDR). It comprises members appointed by each EU Member State to represent its competent authorities, and the European Commission chairs its meetings. The MDCG assists and counsels the Commission and Member States in implementing and interpreting these regulations.

The MDCG plays a central role in shaping the consistent and effective application of the MDR and IVDR by publishing guidance documents on different aspects of the laws, including device classification, borderline determinations, post-market surveillance, clinical evaluation, e‑health technologies, nomenclature, and EUDAMED registration. MDCG guidance documents are not legally binding, but authorities, notified bodies and manufacturers use them as important practical references.

What do MDCG working groups cover?

The MDCG organizes technical work through working groups tasked with specific focus areas, including:

• Notified Bodies Oversight: Harmonizes oversight and conformity assessment practices across Notified Bodies.
• Standards: Coordinates harmonized standards and common specifications under MDR and IVDR.
• Clinical Investigation and Evaluation, Performance Studies and Evaluation: Aligns clinical and performance evaluation requirements for medical devices and IVDs.
• Post-Market Surveillance and Vigilance: Standardizes post-market surveillance, vigilance, and incident reporting.
• Market Surveillance: Supports coordination and consistent approaches among the national authorities that enforce compliance.
• Borderline and Classification: Clarifies product qualification and classification disputes.
• New Technologies: Addresses regulatory challenges for software, AI, and cybersecurity.
• EUDAMED: Supports coordinated implementation of the EU medical device database.
• Unique Device Identification: Ensures harmonized device identification and traceability systems.
• International Matters: Aligns EU positions on global regulatory and IMDRF issues.
• In Vitro Diagnostic Medical Devices: Supports consistent application of IVDR across all IVD-specific activities.
• Nomenclature: Maintains and updates EU device nomenclature for EUDAMED and UDI use.
• Annex XVI Products: Develops specifications for non-medical devices listed in Annex XVI of the MDR.

These working groups develop terms of reference, draft guidance, and help refine 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.

Are MDCG guidance documents legally binding?

MDCG guidance is not legislation and does not replace the MDR or IVDR. It records a coordinated regulatory interpretation and is widely used by competent authorities, notified bodies and manufacturers. Companies should identify the applicable regulation first, then use current guidance to understand how authorities expect the requirement to be implemented.

Where can manufacturers find current MDCG guidance?

The European Commission maintains the official MDCG endorsed guidance index. Because documents can be revised or replaced, manufacturers should confirm the document number, revision and publication date before using it in an EU regulatory strategy.