EU Updates Harmonised Standards Under the MDR

Date

June 29, 2026

Category

EU Regulations

Description

The European Commission has published Commission Implementing Decision (EU) 2026/1231. This Decision updates the list of harmonised standards under the Medical Device Regulation, MDR, Regulation (EU) 2017/745. It amends the existing Commission Implementing Decision (EU) 2021/1182 and covers both updated references to already harmonised standards and newly added harmonised standards. 

The update includes standards related to the biological evaluation of medical devices, symbols and information supplied by the manufacturer, medical electrical equipment, transfusion equipment, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics, and sharps injury protection.

Among the updated standards are several parts of the EN ISO 10993 series on the biological evaluation of medical devices, EN ISO 15223-1:2021/A1:2025 on symbols to be used with information supplied by the manufacturer, and EN IEC 60601-2-83 on home light therapy equipment. Newly added standards include, among others, standards for transfusion equipment, washer-disinfectors, spectacle frames and spectacle lenses, mammary implants, prosthetic components, and sharps injury protection mechanisms.

For medical device manufacturers, this update is relevant because the application of harmonised standards may provide a presumption of conformity with the corresponding requirements of the MDR. 

The full Commission Implementing Decision (EU) 2026/1231 is available in the Official Journal of the European Union on EUR-Lex: Implementing decision - 2026/1231 - EN - EUR-Lex