The Medical Device Coordination Group, abbreviated MDCG in European usage, is the body established under Article 103 of Regulation (EU) 2017/745 in which the Member States coordinate the application of medical device law under the chairmanship of the European Commission. It is not an authority, does not grant approvals, and does not make product-related decisions; rather, it develops recommendations, opinions, and guidance documents and oversees the designation and supervision of Notified Bodies. Its tasks are set out in Article 105 of the Regulation and in the parallel provisions for in vitro diagnostics. In practice, it determines large parts of interpretative practice through its guidance documents, even though these documents are not legally binding.
Composition and Working Methods
Each Member State appoints, for a renewable term of three years, one member and one alternate member with expertise in the field of medical devices, as well as one member and one alternate member for in vitro diagnostics; the same person may cover both areas. The members represent the competent authorities of their Member State, and the Commission publishes the names.
The Group meets regularly and at the request of the Commission or a Member State. It seeks consensus; if consensus is not reached, it decides by a majority of its members, with dissenting views and their reasoning recorded in the minutes. The chair is held by a representative of the Commission, who does not participate in votes.
Subgroups
Article 103 permits the establishment of standing and non-standing subgroups in which stakeholder organizations may be admitted as observers. In practice, the Group operates through more than a dozen thematic subgroups, including those on the supervision of Notified Bodies, standards, clinical investigation and evaluation, post-market surveillance and vigilance, market surveillance, borderline and classification issues, new technologies, the European database, unique device identification, nomenclature, and products without a medical intended purpose.
This structure explains why guidance documents vary considerably in scope and level of detail: they are developed within the relevant specialist subgroup and approved by the Group as a whole.
Tasks under Article 105
Tasks include participation in the assessment of conformity assessment bodies and Notified Bodies, advising the Commission on the Coordination Group of Notified Bodies under Article 49, and contributing to guidance for effective and harmonized implementation, particularly on the designation and supervision of Notified Bodies, the application of the general safety and performance requirements, clinical evaluations and investigations, and vigilance.
In addition, the Group monitors technical progress and assesses whether the requirements of Annex I remain appropriate, contributes to standards, common specifications, and scientific guidelines including product-specific guidelines for clinical investigations of implantable products and Class III products, supports coordination among Member States on classification, regulatory status, vigilance, and market surveillance, and advises on implementation issues.
Legal Nature of the Documents
Guidance documents of the Group are not legally binding. They are not documents of the European Commission and do not represent its official position; only the Court of Justice of the European Union can provide a binding interpretation of Union law. In practice, however, Notified Bodies and authorities treat these documents as authoritative interpretations and as expressions of the state of the art, which means that deviations require justification.
For manufacturers, this results in a dual approach: arguments must be based primarily on the text of the Regulation, but should explicitly address the relevant guidance documents, because auditors and assessors review against these documents.
Distinction from the Commission, Expert Panels, and Notified Bodies
The Commission adopts implementing and delegated acts and is required to consult the Group in certain cases, such as questions of regulatory status or common specifications; the Group’s agreement is not required for this. The expert panels under Article 106 have a different function: they provide scientific opinions on individual clinical evaluation reports in the consultation procedure.
Notified Bodies conduct conformity assessments and coordinate among themselves in their own group under Article 49. The Medical Device Coordination Group thus stands neither above the authorities nor above the Notified Bodies, but harmonizes their practice.
Relevance for clinical trials
For the planning of clinical investigations, the documents of the subgroup on clinical investigation and evaluation are of immediate practical value, because they specify requirements for investigation plans, safety reporting, equivalence evidence, and post-market clinical follow-up reports that the Regulation formulates only in general terms. Those who ignore these specifications risk requests for additional information from the Notified Body after data collection is complete, when corrections are no longer possible.
Since guidance documents are continuously supplemented and revised, monitoring them is part of ongoing study management and not just initial planning. Full-service CROs such as Mediconomics support sponsors and manufacturers in determining the applicable guidance for a project, aligning the investigation plan and documentation accordingly, and documenting justified deviations in a comprehensible manner.
Frequently Asked Questions (FAQ)
Are guidance documents of the Group binding?
No. They are not legally binding and are not Commission documents. The text of the Regulation and the legal acts of the Union are binding; deviations from guidance documents must nevertheless be justified in practice.
Who is represented in the Group?
One member and one alternate member with expertise per Member State, representing the competent authorities. The Commission chairs without voting rights; experts and stakeholders may be invited.
How does it differ from the expert panels?
The Group coordinates implementation and develops guidance. The expert panels under Article 106 provide scientific opinions on individual products within the clinical evaluation consultation procedure.
Regulatory References
- Regulation (EU) 2017/745, Article 103 — Establishment, composition, and working methods of the Coordination Group
- Regulation (EU) 2017/745, Article 105 — Tasks of the Coordination Group
- Regulation (EU) 2017/745, Article 106 — Expert panels and reference laboratories
- Regulation (EU) 2017/745, Article 49 — Coordination Group of Notified Bodies
- Regulation (EU) 2017/746, Article 99 — parallel tasks in the field of in vitro diagnostics
