On 30 January 2026, the Official Journal of the European Union published two new Implementing Decisions. Commission Implementing Decision (EU) 2026/193 and Commission Implementing Decision (EU) 2026/197 significantly update certain harmonised standards, as drafted in support of the Medical Device Regulation (EU) 2017/745 (MDR), and of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) respectively.
The adoption of the revised standards is the result of a request from the European Commission to the European Committee for Standardization (CEN), and the European Committee for Electrotechnical Standardization (Cenelec) to reassess existing harmonised standards, previously developed in support of the medical devices and in vitro diagnostic devices Directives.
MDR: harmonised standards updates and amendments
As of 30 January 2026, Commission Implementing Decision (EU) 2026/193 amends Implementing Decision (EU) 2021/1182, to include references to the newly adopted harmonised standards affecting the following key areas:
- Neurosurgical implants: EN ISO 7197:2024
- Sterilization of health care products: EN ISO 17665:2024
- Non‑active surgical implants (general requirements): EN ISO 14630:2024
- Sterilization of healthcare products: EN ISO 17665:2024
- Biocompatibility evaluation of breathing gas pathways in healthcare applications: EN ISO 18562-1:2024 ; EN ISO 18562-2:2024; EN ISO 18562-3:2024 ; EN ISO 18562-4:2024.
- Non-active surgical implants (Joint replacement implants): EN ISO 21535:2024; EN ISO 21536:2024
- Small-bore connectors for liquids and gases in healthcare applications: EN ISO 80369-2:2024
Moreover, the Decision introduces amendments to the following standards:
- Biological evaluation of medical devices: EN ISO 10993-4:2017/A1:2025
- Clinical investigation of medical devices for human subjects: EN ISO 14155:2020/A11:2024
IVDR: harmonised standards updates
As of 30 January 2026, with Commission Implementing Decision (EU) 2026/197, the Annex to Implementing Decision (EU) 2021/1195 is amended to include the following standards, now harmonised under the IVDR:
- Sterilization of health care products: EN ISO 17665:2024
- Information supplied by the manufacturer (labelling): EN ISO 18113-1:2024; EN ISO 18113-2:2024; EN ISO 18113-3:2024; EN ISO 18113-4:2024; EN ISO 18113-5:2024.
The updated references ensure that the harmonised standards reflect the latest scientific and technical progress, and the corresponding essential requirements, thereby supporting manufacturers in demonstrating conformity with the MDR and IVDR.
For any questions on compliance of your medical devices, contact MDlaw Team here or at mdlaw@obelis.net.
References
EUR-Lex (2021). Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council. Retrieved on 06/02/2026.
EUR-Lex (2021). Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council. Retrieved on 06/02/2026.
EUR-Lex (2026). Commission Implementing Decision (EU) 2026/193 of 28 January 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical devices for human subjects, non-active surgical implants, sterilization of health care products, biocompatibility evaluation of breathing gas pathways in healthcare applications and small-bore connectors for liquids and gases in healthcare applications. Retrieved on 06/02/2026.
EUR-Lex (2026). Commission Implementing Decision (EU) 2026/197 of 28 January 2026 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of health care products and information supplied by the manufacturer (labelling). Retrieved on 06/02/2026.
Leave a Reply