On 10 November 2026 the Official Journal of the European Union published Commission Implementing Decision (EU) 2026/2479 of 9 November 2026, which amends Implementing Decision (EU) 2021/1182 and cites new harmonised standards in support of Regulation (EU) 2017/745 on medical devices (MDR). The decision entered into force on the day of publication. Annex points (1) and (3), which delete the references to EN ISO 11137-1:2015 and amendment A2:2019 and to EN ISO 14155:2020 and amendment A11:2024, apply from 10 May 2028. No further procedural step is scheduled for this decision.
EU manufacturers of radiation-sterilised medical devices, sponsors and manufacturers running clinical investigations, manufacturers of natural rubber latex male condoms, of washer-disinfectors and of devices that rely on biological evaluation under EN ISO 10993, manufacturers of surgical laser and intense-light medical electrical equipment, and authorised representatives and importers of devices using small-bore connectors must map technical documentation, clinical investigation plans and supplier specifications to the standards cited by Implementing Decision (EU) 2026/2479, and finish the move off EN ISO 11137-1:2015/A2:2019 and EN ISO 14155:2020/A11:2024, by May 10, 2028, or a device still resting only on the withdrawn references loses the Article 8 presumption of conformity for the requirements those standards covered, and a notified body can refuse the technical file. A harmonised standard is a European standard whose reference the Commission publishes in the Official Journal, so that a device conforming to it is presumed to meet the MDR requirements that standard covers.
What does Implementing Decision (EU) 2026/2479 change in the MDR standards list?
Commission Implementing Decision (EU) 2026/2479 rewrites the Annex to Implementing Decision (EU) 2021/1182. Recital (13) states that compliance with a harmonised standard confers a presumption of conformity from the date the reference is published in the Official Journal. Only the two deletions are deferred. The parallel IVDR act is Implementing Decision (EU) 2026/2481, and this decision is not the MDR and IVDR targeted revision.
| Reference | What the Annex does | From when |
|---|---|---|
| EN ISO 11137-1:2026 (ISO 11137-1:2025), radiation sterilization | Inserted as entry 3a | 10 November 2026 |
| EN ISO 14155:2026, clinical investigation, good clinical practice | Inserted as entry 39a | 10 November 2026 |
| EN ISO 4074:2026, natural rubber latex male condoms | Added as entry 66 | 10 November 2026 |
| EN ISO 10993-6:2026 and EN ISO 10993-7:2026, biological evaluation | Added | 10 November 2026 |
| EN ISO 15883-6:2026, washer-disinfectors | Added | 10 November 2026 |
| EN IEC 60601-2-22:2020/A11:2026 and EN IEC 60601-2-57:2026/A11:2026 | Added, surgical laser and intense light | 10 November 2026 |
| EN ISO 80369-1:2026, small-bore connectors | Added | 10 November 2026 |
| EN ISO 11137-1:2015 and A2:2019, entry 3 | Reference deleted | 10 May 2028 |
| EN ISO 14155:2020 and A11:2024, entry 39 | Reference deleted | 10 May 2028 |
Who has to realign files to the new MDR harmonised standards?
Exposure follows the product families named in the Annex. Manufacturers placing radiation-sterilised devices on the Union market, sponsors and manufacturers of clinical investigations, manufacturers of natural rubber latex male condoms, of washer-disinfectors and of devices evaluated under EN ISO 10993-6 or EN ISO 10993-7, manufacturers of surgical lasers and intense-light equipment, and authorised representatives and importers of devices that use small-bore connectors, are the actors whose files rest on these references. Notified bodies assess a claim of the Article 8 presumption against the cited standard. Obsidian has recorded 16 dated steps in the life of MDR since 5 April 2017, as of November 2026.
What must those actors have in place before May 10, 2028?
The new citations can be used from 10 November 2026. Recital (12) defers the deletion of the 2015 sterilization reference and the 2020 clinical-investigation reference so that manufacturers and other economic operators can adapt the processes and devices those standards cover.
- Map each presumption claim to the 2026 reference, or keep EN ISO 11137-1:2015 or EN ISO 14155:2020 only with a dated plan to leave it before 10 May 2028.
- Revalidate radiation sterilization against EN ISO 11137-1:2026 where the file still cites the 2015 edition or A2:2019.
- Move clinical investigation plans from EN ISO 14155:2020 and A11:2024 to EN ISO 14155:2026.
- Align condom, biological-evaluation, washer-disinfector, laser, intense-light and small-bore connector specifications to the newly cited 2026 standards, which did not previously support an MDR presumption.
- Tell the notified body which reference the file will use after 10 May 2028, and amend supplier agreements that still name the withdrawn editions.
What does the MDR presumption of conformity lose on 10 May 2028?
Article 8(1) of Regulation (EU) 2017/745 presumes conformity only with the requirements covered by harmonised standards whose references stay in the Official Journal. From 10 May 2028, entries 3 and 39 of the Annex to Implementing Decision (EU) 2021/1182 are deleted, so EN ISO 11137-1:2015 with A2:2019 and EN ISO 14155:2020 with A11:2024 no longer confer that presumption. A notified body can refuse a technical file that still rests only on those references. The other new citations are not withdrawn on that date. Continuous, per-jurisdiction monitoring of the Official Journal is what surfaces the next MDR harmonised-standard citation when it is published.
Check whether any device, clinical investigation or supplier specification still cites EN ISO 11137-1:2015, A2:2019, EN ISO 14155:2020 or A11:2024. Confirm which 2026 standard the file will use, brief the responsible leads on the 10 May 2028 withdrawal, and record the 10 November 2026 citations in the standards register. Obsidian tracks each new MDR citation as the Official Journal publishes it.
