Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · EU medical devices: MDR

MDCG guidance

Also known as: Medical Device Coordination Group, MDCG, MDCG documents

MDCG guidance documents are endorsed by the Medical Device Coordination Group, the group of member-state experts established by Article 103 of the EU Medical Device Regulation (EU) 2017/745, which also acts under the IVDR. They explain how the MDR and IVDR are to be applied; they are not legally binding, but notified bodies and competent authorities use them as the reference interpretation.

  • EU
  • MDR
  • IVDR

In one sentence

MDCG guidance: documents endorsed by the Medical Device Coordination Group that explain the MDR and IVDR. Not binding, but the reference for notified bodies.

Example

A software manufacturer uses MDCG 2019-11 to decide whether its app is medical device software and how Rule 11 classifies it, and cites the guidance in its qualification and classification rationale.

How it applies

  • Numbering: Documents are numbered by year and sequence, for example MDCG 2019-11, and revised versions carry a “rev.” suffix. Always cite the revision you used.
  • Frequently used documents: MDCG 2019-11 (qualification and classification of software), MDCG 2019-16 (cybersecurity), MDCG 2019-9 (SSCP), MDCG 2020-5 (clinical evaluation, equivalence), MDCG 2022-21 (PSUR), MDCG 2023-1 (health institution exemption) and MDCG 2025-6 (interplay between MDR/IVDR and the AI Act).
  • Where to find them: The European Commission publishes them on its medical devices guidance page, grouped by topic.
  • Status: Guidance can change faster than the regulations. Check for new revisions when you revise a document that relies on one.
  • Technical documentation: Cite the MDCG document and revision where your rationale depends on it, for example in the classification rationale, clinical evaluation or PSUR. Following a guidance document supports an argument; it does not by itself show conformity.

MDCG guidance vs. harmonized standards and common specifications

A harmonized standard cited in the Official Journal gives a presumption of conformity with the requirements it covers. Common specifications under Article 9 MDR also give a presumption, and manufacturers must follow them unless they justify an equivalent solution. MDCG guidance gives neither: it is an interpretation, however influential.