Medical Device Coordination Group (MDCG)

A Key Reference for Non-EU Manufacturers Entering the European Market

What is the Medical Device Coordination Group (MDCG)?

For manufacturers based outside the European Union, navigating the European regulatory framework can be complex and unfamiliar. One of the most important bodies supporting a consistent application of EU medical device legislation is the Medical Device Coordination Group (MDCG).

The MDCG is a European expert group established in 2017 to support the implementation of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Its role is to advise and assist the European Commission and EU Member States in ensuring a harmonised application of both regulations across Europe.

The group operates through 13 specialised sub-groups, whose members are appointed by EU Member States for a three-year term. In addition, relevant stakeholder organisations may apply to participate in selected meetings.

For non-EU manufacturers, the MDCG plays a crucial role by:

• reducing interpretation differences between EU Member States
• aligning expectations of Notified Bodies
• increasing regulatory predictability during conformity assessments

MDCG Guidance Documents – Practical Orientation for MDR and IVDR Compliance

What are MDCG Guidances?

The MDCG regularly publishes Guidance Documents that address key regulatory topics related to MDR and IVDR implementation. These documents support manufacturers, Notified Bodies and Competent Authorities in translating legal requirements into practical and auditable processes.

Typical topics include:

• device classification
• clinical evaluation and clinical evidence
• post-market surveillance and vigilance
• EUDAMED registration
• UDI implementation
• emerging and innovative technologies

It is important to note that MDCG Guidances are not legally binding, as clearly stated in each document:

“Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.”

However, in regulatory practice, MDCG Guidances are widely treated as a de facto standard. Notified Bodies and authorities frequently use them as a reference during audits, technical documentation reviews and conformity assessments.

For non-EU manufacturers, aligning with MDCG Guidances significantly reduces:

• clarification loops with Notified Bodies
• regulatory deficiencies
• approval delays

MDCG Sub-Groups – Focused Expertise Across Regulatory Topics

The MDCG operates through 13 thematic sub-groups, each responsible for specific regulatory domains, including:

• Notified Body Oversight (NBO)
• Clinical Investigation and Evaluation (CIE)
• Market Surveillance & Vigilance (PMSV)
• Borderline and Classification (B&C)
• EUDAMED
• Unique Device Identification (UDI)
• New Technologies (including AI and Software as a Medical Device)
• In Vitro Diagnostics (IVD)
• International Affairs
• Products under Annex XVI

This structure enables targeted, expert-driven guidance for even the most complex regulatory challenges — a major advantage for manufacturers without an established EU regulatory footprint.

Advisory Role – But a Practical Benchmark for EU Compliance

The MDCG does not have formal decision-making authority. Its function is advisory and coordinative, with the objective of promoting a harmonised application of MDR and IVDR across all EU Member States.

In practice, MDCG outputs strongly influence:

• Notified Body expectations
• regulatory interpretations during audits
• consistency of EU-wide enforcement

For non-EU manufacturers, MDCG Guidances therefore serve as a reliable benchmark for regulatory readiness.

Why MDCG Guidances Are Essential for Non-EU Manufacturers

The MDR and IVDR are widely regarded as the most stringent medical device regulations globally. Manufacturers from the US and other non-EU regions often face challenges in areas such as:

• MDR/IVDR device classification
• clinical evaluation strategies
• leveraging legacy or equivalence data
• post-market surveillance and vigilance systems
• EUDAMED data requirements
• UDI implementation
• AI-based medical devices and SaMD

MDCG Guidances provide clear, structured pathways for interpreting and implementing these requirements in a way that aligns with EU regulatory expectations.

IMDRF – The Global Regulatory Perspective

In addition to the MDCG, the International Medical Device Regulators Forum (IMDRF) plays an important role for globally active manufacturers.

While the MDCG focuses on EU-specific implementation of MDR and IVDR, the IMDRF aims to harmonise medical device regulations worldwide. Members include regulatory authorities from the EU, United States, Canada, Japan and Australia.

The MDCG frequently builds on IMDRF principles, particularly in areas such as:

• global regulatory convergence
• innovative technologies
• Software as a Medical Device (SaMD)
• artificial intelligence in medical devices

IMDRF documents, like MDCG Guidances, are non-binding, but serve as strategic reference documents for international regulatory strategies.