The European Commission has published two binding implementing decisions updating the lists of harmonised standards that confer presumption of conformity under the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Commission Implementing Decision (EU) 2026/2479 (MDR, C/2026/7848) and Commission Implementing Decision (EU) 2026/2481 (IVDR, C/2026/7839) were both adopted on 9 November 2026, published in the Official Journal on 10 November 2026, and entered into force on 10 November 2026.
From 10 November 2026, manufacturers can cite nine new MDR entries and one new IVDR entry for the requirements those standards cover. The earlier references for radiation sterilization under both regulations and for clinical investigations under the MDR remain listed until 10 May 2028.
Key Dates and Legal Status
Harmonised standards remain voluntary technical documents under EU law, but Official Journal citation determines whether using a standard confers a legal presumption of conformity with the requirements of the applicable regulation that the standard, or the relevant part of it, covers.
| Milestone | Date | Legal Basis |
|---|---|---|
| Commission adoption | 9 November 2026 | Decisions (EU) 2026/2479 and (EU) 2026/2481 |
| Official Journal publication and entry into force | 10 November 2026 | Article 2, paragraph 1 of both Decisions (immediate effect for new entries) |
| Deletion of superseded MDR Entries 3 and 39 and IVDR Entry 2 | 10 May 2028 | Article 2, paragraph 2 and Annex points (1) and (3) of Decision (EU) 2026/2479 and point (1) of Decision (EU) 2026/2481 |
| Pure Global analysis: co-existence window | 18 calendar months | Calculated from 10 November 2026 to 10 May 2028 |
Recitals (1), (8), and (13) of (EU) 2026/2479 and Recitals (1), (6), and (11) of (EU) 2026/2481 explain that compliance with a harmonised standard creates a presumption of conformity with the essential requirements it aims to cover, while Recital (12) of (EU) 2026/2479 and Recital (10) of (EU) 2026/2481 defer withdrawal of the superseded standards so manufacturers and economic operators have sufficient time to adapt their processes and devices.
Superseded MDR and IVDR Standards Withdrawn on 10 May 2028
Both Decisions amend the original 2021 implementing decisions—(EU) 2021/1182 for MDR and (EU) 2021/1195 for IVDR—to add revised standards alongside scheduled deletions. The radiation sterilization update applies under both regulations. The clinical investigation update appears in the MDR decision.
| Regulation | Old Entry (Withdrawn 10 May 2028) | New Entry (Effective 10 November 2026) | Subject |
|---|---|---|---|
| MDR | Entry 3: EN ISO 11137-1:2015 and EN ISO 11137-1:2015/A2:2019 | Entry 3a: EN ISO 11137-1:2026 (ISO 11137-1:2025) | Sterilization of health care products — Radiation — Part 1 |
| MDR | Entry 39: EN ISO 14155:2020 and EN ISO 14155:2020/A11:2024 | Entry 39a: EN ISO 14155:2026 (ISO 14155:2026) | Clinical investigation of medical devices for human subjects — GCP |
| IVDR | Entry 2: EN ISO 11137-1:2015 and EN ISO 11137-1:2015/A2:2019 | Entry 2a: EN ISO 11137-1:2026 (ISO 11137-1:2025) | Sterilization of health care products — Radiation — Part 1 |
Pure Global analysis: The Commission cited the amendment EN ISO 14155:2020/A11:2024 in Decision (EU) 2026/193, adopted on 28 January 2026. For new MDR investigations that will run during or beyond the overlap, sponsors can review which edition their protocol and documentation will reference, and assess the impact of the older reference leaving the list on 10 May 2028.
Seven Newly Added MDR Standards (Entries 66 to 72)
Point (5) of the Annex to Decision (EU) 2026/2479 adds seven MDR entries. Recital (5) identifies the earlier references, which were absent from the Official Journal list for the MDR:
- Entry 66 — EN ISO 4074:2026 (ISO 4074:2026): Natural rubber latex male condoms — Requirements and test methods (superseding EN ISO 4074:2015 referenced in Recital 5).
- Entry 67 — EN ISO 10993-6:2026 (ISO 10993-6:2026): Biological evaluation of medical devices — Part 6: Tests for local effects after implantation (replacing EN ISO 10993-6:2016).
- Entry 68 — EN ISO 10993-7:2026 (ISO 10993-7:2026): Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals (replacing EN ISO 10993-7:2008, A1:2022, and AC:2009).
- Entry 69 — EN ISO 15883-6:2026 (ISO 15883-6:2026): Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment (replacing EN ISO 15883-6:2015).
- Entry 70 — EN IEC 60601-2-22:2020 + EN IEC 60601-2-22:2020/A11:2026: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- Entry 71 — EN IEC 60601-2-57:2026 + EN IEC 60601-2-57:2026/A11:2026: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use (replacing EN 60601-2-57:2011).
- Entry 72 — EN ISO 80369-1:2026 (ISO 80369-1:2025): Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements (replacing EN ISO 80369-1:2018).
Practical Decisions and Scope Boundaries
Pure Global analysis: These Official Journal citations establish legal metadata, effective dates, and presumption-of-conformity scope, while the detailed clause text of each ISO, IEC, and CEN/CENELEC standard remains paywalled. Regulatory, clinical, and quality teams should treat the citations as an immediate trigger for targeted gap reviews rather than assuming zero technical change between editions:
- Separate November 2026 withdrawals from the June 2026 MDR decision: Keep the 10 May 2028 transition deadline for EN ISO 11137-1:2015 + A2:2019 and EN ISO 14155:2020 + A11:2024 separate from the earlier 15 December 2027 and 15 June 2031 withdrawal dates covered in our review of June 2026 MDR harmonised standards Decision (EU) 2026/1231.
- Update GSPR checklists for newly harmonized files: For devices that rely on earlier editions of ISO 4074, ISO 10993-6, ISO 10993-7, ISO 15883-6, IEC 60601-2-22, IEC 60601-2-57, or ISO 80369-1, compare the newly cited versions and applicable amendments against your existing evidence before updating the MDR Annex I GSPR checklist and technical documentation where appropriate.
- Coordinate radiation sterilization across MDR and IVDR portfolios: Manufacturers operating shared gamma or e-beam sterilization lines under both MDR and IVDR can assess the shared sterilization process against EN ISO 11137-1:2026 and document how the results apply to each portfolio before 10 May 2028.
- Track future OJ citations centrally: Monitor the European Commission's harmonised standards portal for later citations and the consolidated MDR and IVDR lists.
