What it is and where it stands
Regulation (EU) 2017/745, the Medical Device Regulation, sets the rules for placing medical devices on the EU market. Three things shape how US companies should read it in late 2026.
1. Extended transition deadlines. Regulation (EU) 2023/607 extended the time legacy devices (certified under the old directives) can stay on the market, subject to conditions, and removed the sell-off date:
| Device class | Legacy device deadline |
|---|---|
| Class III and class IIb implantable | 31 December 2027 |
| Other class IIb, class IIa, class Im and Is | 31 December 2028 |
2. A simplification proposal. On 16 December 2025 the Commission proposed a targeted revision of the MDR and IVDR (COM(2025) 1023). Ideas include moving some devices and software to lower classes, replacing the five-year certificate limit with risk-based reviews, broader use of literature and in silico evidence, longer timelines for non-critical incident reports, and new breakthrough and orphan pathways. It must pass the European Parliament and Council, and the Commission expects adoption around Q2 2027. Until then, the MDR applies in its current form.
3. EUDAMED is now mandatory in part. Four EUDAMED modules became mandatory on 28 May 2026 (see the EUDAMED article in this series).
Where to find it
- EUR-Lex: the Official Journal text and consolidated versions, via the ELI link eur-lex.europa.eu/eli/reg/2017/745/oj.
- European Commission medical devices pages: implementing acts, news, and MDCG guidance.
Reuse terms
EUR-Lex reuse is governed by Commission Decision 2011/833/EU, and Commission content is generally licensed under CC BY 4.0 unless otherwise indicated. That means:
- Attribution to the source is required, and changes must be indicated.
- Only the Official Journal is authentic. The electronic OJ has been authentic since July 2013. Consolidated versions are documentation tools, not legally authentic texts.
- Third-party material and logos are outside the reuse licence.
- Harmonised standards referenced by the MDR (EN ISO texts) are not part of EUR-Lex and are copyrighted separately.
Using the MDR in AI and RAG
- Index the consolidated version for readability, but record its consolidation date and keep links to the OJ originals of the MDR and each amending act.
- Store the CELEX number and ELI on every chunk so citations are exact.
- Add a “legacy device” layer for Regulation 2023/607 so answers about deadlines cite the amending act.
- Keep the 2025 proposal in a separate “proposed” collection, clearly labeled as not in force.
- Link MDCG guidance to the articles it interprets, labeled nonbinding.
- Include an attribution line in exported outputs, for example “Source: EUR-Lex, © European Union.”
Common mistakes
- Treating the December 2025 proposal as adopted law.
- Citing a consolidated version as the authentic legal text.
- Using a consolidated version that predates the latest amendment.
- Pasting harmonised standards into the index alongside the regulation.
Checklist
- Consolidated text stored with consolidation date
- OJ originals linked for the MDR and amending acts
- CELEX and ELI metadata on every chunk
- Proposal stored separately and labeled
- Attribution line in outputs
- Standards excluded unless licensed
How AskDona helps
AskDona checks your technical documentation, clinical evaluation, and PMS plans against the MDR articles and annexes you select. Every finding cites the article and the version date of the text it used, so you can show reviewers exactly which version applied.
Run a sample MDR technical documentation check
AskDona shows the evidence; your regulatory team decides.
Editor’s note. This article is general information, not legal advice. The “conditional use” rating comes from our source list and is a first-pass judgment, not a legal opinion.
FAQ
Has the MDR been replaced by the 2025 proposal? No. The proposal is still in the legislative process. The MDR applies as it stands.
When do legacy devices have to be MDR certified? Under Regulation 2023/607, by 31 December 2027 for class III and IIb implantables and 31 December 2028 for other classes, if the conditions are met.
Can I put MDR text into a commercial AI tool? Generally yes, with attribution, under the Commission’s reuse policy. Third-party content, logos, and standards are excluded.
Which version should my AI cite? Cite the OJ text as authentic, and use the consolidated version for reading, with its date.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| EUR-Lex legal notice | Decision 2011/833/EU, OJ authentic since July 2013, consolidated versions not authentic |
| European Commission legal notice | CC BY 4.0, attribution, indicate changes, exclusions |
| Regulation (EU) 2023/607 on EUR-Lex | Legacy device deadlines 2027 and 2028 |
| Baker McKenzie: EU 2025 proposal to simplify MDR/IVDR (Dec 19, 2025) | Proposal date and contents, expected adoption Q2 2027 |
| Complife: MDR and IVDR reform (Jan 16, 2026) | COM(2025) 1023; MDR and IVDR remain fully applicable |
| European Commission: EUDAMED overview | Four modules mandatory from 28 May 2026 |