MDR/IVDR Reform Updates: WTO Publication & Redlined Versions
16 January 2026
Jan 2026 “In All Other News”: EMDN, EUDAMED, WET Updates, and more
2 February 2026European Harmonized Standards
The following Casus Resource has been updated: Consolidated List of EU MDR/IVDR Harmonized Standards & Common Specifications
EU MDR
Twelve new standards were harmonized: HERE
Commission Implementing Decision (EU) 2026/193 formally harmonizes 48 of the 277 requested standards (17%):
| Reference number of the standard | Title of the standard |
|---|---|
| EN ISO 7197:2024 | Neurosurgical implants – Sterile, single-use hydrocephalus shunts (ISO 7197:2024) |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) EN ISO 10993-4:2017/A1:2025 |
EN ISO 14155:2020 | Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020) EN ISO 14155:2020/A11:2024 |
EN ISO 14630:2024 | Non-active surgical implants – General requirements (ISO 14630:2024) |
EN ISO 17665:2024 | Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) |
EN ISO 18562-1:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024) |
EN ISO 18562-2:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024) |
EN ISO 18562-3:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024) |
EN ISO 18562-4:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2024) |
EN ISO 21535:2024 | Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2023) |
EN ISO 21536:2024 | Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023) |
| EN ISO 80369-2:2024 | Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06)’ |
EU IVDR
Six new standards were harmonized: HERE
Commission Implementing Decision (EU) 2026/197 formally harmonizes 23 of the 49 requested standards (47%):
| Reference number of the standard | Title of the standard |
|---|---|
| EN ISO 17665:2024 | Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) |
| EN ISO 18113-1:2024 | In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022) |
| EN ISO 18113-1:2024 | In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022) |
| EN ISO 18113-1:2024 | In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022) |
| EN ISO 18113-1:2024 | In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022) |
| EN ISO 18113-1:2024 | In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)’. |
Case T‑631/24: ISO & IEC v European Commission
Court case T-631/24, initiated by ISO & IEC against the EU Commission, is still pending. A judgment may not arrive before late 2026.
Essentially, the international standards bodies ISO and IEC sued the European Commission over who controls access to certain technical standards. The reason for the lawsuit is that the Commission decided some of these standards should be made publicly accessible, beyond what previous court rulings strictly require. ISO/IEC argue this goes too far and undermines their copyright and business model.
To reduce legal risk during this dispute, the Commission indicated it would prioritize OJEU publications to “purely EN” standards (drafted and owned entirely within the European system), rather than standards relying on ISO/IEC copyright. However, since the Commission has now harmonized additional EN ISO/EN IEC standards, it is not clear from public information whether this is due to a new agreement with ISO/IEC or simply a decision that harmonization can continue while the court case is still ongoing.
UK Designated Standards
The MHRA has updated its list of designated standards: HERE
These standards are applicable under the UK MDR 2002 (as amended), related to UKCA Marking of medical devices.
Numerous changes were made, such as replacing EN ISO 14971:2012 with EN ISO 14971:2019.
The MHRA has kept the previous 2021 list of standards available for download. Therefore, they can be easily compared against the new 2026 list. Please see below an example of changes.
