What it is
The International Medical Device Regulators Forum (IMDRF) brings together device regulators, including FDA, to agree on common approaches. Its technical documents shape national rules on topics such as:
- Software as a Medical Device (SaMD)
- Good Machine Learning Practice (GMLP) and other AI/ML documents
- Medical device cybersecurity
- Unique Device Identification (UDI)
- Regulatory submissions, clinical evaluation, adverse event terminology, and IVD classification
What is new. On 1 September 2026 IMDRF published its Document Implementation Report 2026 (IMDRF/MC/N84 FINAL:2026). It shows, for each technical document, whether each member regulator has implemented it fully, partly, or not at all. This is the best quick way to see how far a document like GMLP actually reaches into national rules.
Where to find it
- IMDRF website document library, organized by working group and status.
- Member regulators’ sites, where adopted versions appear as national guidance.
Note: the IMDRF document library page blocked automated retrieval when we checked, which is itself a signal to avoid scraping.
Reuse terms: why “check required”
The copyright notice on IMDRF documents (as on the 2026 implementation report) allows you to download, display, print, translate, modify, and reproduce the work for personal, research, educational, or internal organisational use, provided:
- there is no commercial purpose,
- disclaimers are kept, and
- IMDRF is acknowledged.
All other rights are reserved; other reproduction needs written permission from the IMDRF Secretariat. Incorporating or translating a document does not imply IMDRF endorsement.
That is why our note holds: a publicly available PDF is not automatically fit for full-text use in a commercial AI product.
Using IMDRF documents in AI and RAG
- Decide the use case first. An internal knowledge base for your own regulatory team is closer to “internal organisational use” than a customer-facing product.
- For commercial or external use, ask the IMDRF Secretariat for written permission.
- Keep disclaimers and the acknowledgement with every chunk.
- Prefer member regulators’ adopted versions (for example, FDA guidance) where their reuse terms are more open.
- Record document code, version, and date (for example, N88).
- Use the implementation report to show which regulators have adopted each document.
Common mistakes
- Treating “publicly available” as “free for commercial AI use.”
- Stripping IMDRF disclaimers when chunking.
- Citing an IMDRF document as if it were binding on a regulator that has not implemented it.
- Scraping the IMDRF site.
Checklist
- Use case classified: internal or commercial
- Permission requested for commercial or external use
- Disclaimers and acknowledgement kept
- Regulator-adopted versions preferred where available
- Document code, version, and date recorded
- Implementation status checked
How AskDona helps
AskDona lets your team check SaMD and AI-device documentation against the regulator-adopted versions of IMDRF principles, such as FDA guidance, while keeping any IMDRF source text within the scope your license allows.
Run a sample GMLP alignment check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. The “check required” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
Are IMDRF documents free to use? Free to download and use for personal, research, educational, or internal organisational purposes without commercial purpose. Other uses need permission.
Can I put IMDRF documents into a commercial AI product? Not without checking. Commercial use is outside the standard notice, so ask the IMDRF Secretariat.
What is the IMDRF implementation report? A yearly report showing which members have implemented each technical document. The 2026 edition is dated 1 September 2026.
Are IMDRF documents binding? No. They become effective only as each regulator adopts them.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| IMDRF Document Implementation Report 2026 (PDF) | Topics covered, implementation status, copyright and reuse terms |