What it is
MDCG guidance documents are endorsed by the Medical Device Coordination Group under Article 105 MDR and Article 99 IVDR. They are drafted with stakeholders and numbered “MDCG year-number-revision.” The Commission’s page is clear: “The documents on this page are not legally binding.” They present a common understanding of how the MDR and IVDR should be applied, and they are reviewed regularly, with obsolete ones moved to a separate list.
Notified bodies and authorities rely on them heavily, which is why they belong in any device knowledge base, but as a separate layer from the law.
What is new in 2026
The MDCG has been busy, especially on EUDAMED and UDI as EUDAMED modules became mandatory. Recent items listed on the Commission page include:
- MDCG 2020-16 rev.5 on IVDR classification rules (September 2026).
- MDCG 2026-5 on UDI assignment between manufacturers and distributors (July 2026).
- MDCG 2026-4 on managing SS(C)P in EUDAMED after mandatory use (June 2026).
- MDCG 2021-5 rev.1 Appendix on the transition to the “EU REP” symbol (June 2026).
- MDCG 2026-1 to 2026-3 and MDCG 2021-12 rev.2 on the EMDN nomenclature (April 2026).
- Borderline manual version 5 (April 2026).
Where to find it
The European Commission’s “Guidance: MDCG endorsed documents and other guidance” page groups documents by topic, including classification, clinical evaluation, EUDAMED, IVDs, notified bodies, PRRC, PMS and vigilance, standards, and UDI. Separate pages list obsolete guidance and work in progress.
Reuse terms
Commission website content is generally licensed under CC BY 4.0 unless otherwise indicated: reuse is allowed with credit and an indication of changes. Logos and third-party material are excluded. Our condition, store separately from the regulations, is about accuracy: MDCG documents interpret the law but are not the law.
Using MDCG guidance in AI and RAG
- Create a distinct “MDCG guidance” collection, separate from MDR and IVDR text.
- Store the reference with its revision (for example, 2020-16 rev.5) and publication date.
- Move superseded revisions to an archive as soon as a new one appears.
- Map each document to the articles or annexes it interprets so answers show law first, then guidance.
- Label every MDCG answer “not legally binding.”
- Check the obsolete list monthly.
Common mistakes
- Mixing MDCG text into the regulation index so answers present guidance as law.
- Keeping rev.4 and rev.5 of the same document live together.
- Missing new EUDAMED-related guidance after the May 2026 mandatory date.
- Dropping CC BY attribution.
Checklist
- Separate MDCG collection
- Reference, revision, and date on each file
- Superseded revisions archived
- Mapped to MDR and IVDR articles
- “Not legally binding” label in outputs
- Monthly check of obsolete list
How AskDona helps
AskDona checks your files against the MDR or IVDR first and then the relevant MDCG guidance, keeping the two layers visibly separate in every finding. Each citation shows the MDCG reference and revision used.
Run a sample MDCG-aligned classification check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. The “CC BY 4.0, conditional use” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
Is MDCG guidance legally binding? No. The Commission states it is not legally binding, though notified bodies widely rely on it.
How are MDCG documents numbered? “MDCG year-number-revision,” for example MDCG 2020-16 rev.5.
What is the newest IVDR classification guidance? MDCG 2020-16 rev.5, listed for September 2026.
Can I reuse MDCG documents in a commercial AI tool? Generally yes under CC BY 4.0 with credit, but keep them separate from the regulations.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| European Commission: MDCG endorsed documents and other guidance | Not legally binding, numbering, topics, 2026 documents |
| European Commission legal notice | CC BY 4.0 reuse and exclusions |
| European Commission: EUDAMED overview | EUDAMED mandatory date context |