What it is and where it stands
Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation, has applied in the EU since 26 May 2022. It is the regulation with the most moving dates, which is exactly why our note focuses on version tracking.
Extended transition deadlines. Regulation (EU) 2024/1860 extended the time legacy IVDs can stay on the market:
| IVDR class | Deadline | Apply to notified body by | Written NB agreement by |
|---|---|---|---|
| Class D | 31 December 2027 | 26 May 2025 | 26 September 2025 |
| Class C | 31 December 2028 | 26 May 2026 | 26 September 2026 |
| Class B and class A sterile | 31 December 2029 | 26 May 2027 | 26 September 2027 |
Conditions apply: the device must still comply with the old directive, must not change significantly in design or intended purpose, and the manufacturer needed an IVDR quality management system by 26 May 2025. Class C manufacturers should note the 26 September 2026 agreement deadline has just passed.
The same 2024 regulation set up the gradual roll-out of EUDAMED and added a duty to notify interruption or discontinuation of supply.
Simplification proposal. The Commission’s 16 December 2025 proposal (COM(2025) 1023) would amend the IVDR as well as the MDR. It is not yet law.
Where to find it
- EUR-Lex: the IVDR (CELEX 32017R0746), its consolidated versions, and amending acts such as 2024/1860 (CELEX 32024R1860).
- National competent authorities, such as Ireland’s HPRA, publish clear summaries of the transitional provisions.
- MDCG guidance on IVD classification and performance evaluation, labeled nonbinding.
Reuse terms
As with the MDR, EUR-Lex content is reusable under Commission Decision 2011/833/EU with attribution, and Commission content is generally CC BY 4.0. Only the Official Journal is authentic; consolidated versions are not. Third-party material, logos, and harmonised standards are excluded.
Using the IVDR in AI and RAG
- Record CELEX and consolidation date on every chunk.
- Build a deadline table from the amending act itself, and cite the act (2024/1860), not only the consolidated text.
- Tag chunks with the device classes they affect so answers can be filtered by class.
- Re-index when a new consolidated version appears, and keep the previous one in an archive.
- Store national authority summaries separately, labeled as secondary sources.
- Keep the proposal out of “current law” answers.
Common mistakes
- Quoting the original 2017 deadlines that have since been extended.
- Missing the notified body application and agreement milestones, which are conditions for the extension.
- Citing a consolidated text without its date.
- Treating the 2025 proposal as in force.
Checklist
- CELEX and consolidation date on every chunk
- Deadline table cites Regulation 2024/1860
- Class tags applied
- Previous consolidated versions archived
- Secondary summaries labeled
- Proposal stored separately
How AskDona helps
AskDona checks your IVD technical files and performance evaluation reports against the IVDR text you select and shows the article, CELEX, and version date behind each finding. Class-specific deadlines can be checked against your product portfolio.
Run a sample IVDR transition readiness 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
What is the IVDR deadline for class D devices? 31 December 2027, if the conditions in Regulation 2024/1860 are met.
What is a CELEX number? The unique identifier EUR-Lex gives each legal act. The IVDR is 32017R0746.
Is the consolidated IVDR legally binding? The law is binding, but the consolidated text is not the authentic version. The Official Journal is.
Will the 2025 proposal change these deadlines? It may change parts of the IVDR, but nothing changes until it is adopted and published.
References
All pages opened and checked by October 26, 2026.
| Source | What it supports |
|---|---|
| HPRA: IVDR transitional provisions | Deadlines by class, NB application and agreement dates, conditions |
| Regulation (EU) 2024/1860 on EUR-Lex | Title: EUDAMED roll-out, supply interruption notice, IVD transitional provisions |
| European Commission: New regulations | IVDR applicable from 26 May 2022 |
| EUR-Lex legal notice | Reuse, OJ authenticity, consolidated versions |
| Baker McKenzie: EU 2025 proposal to simplify MDR/IVDR | Proposal date and status |