The European Commission has published Commission Implementing Decision (EU) 2026/1231, updating the references of harmonised standards supporting Regulation (EU) 2017/745 on medical devices. The Decision was published in the Official Journal of the European Union on 17 June 2026 and entered into force on the date of publication.
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The update introduces new and amended references covering biological evaluation of medical devices, symbols used with 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 relevant updates are new or amended references for:
- the EN ISO 10993 series on biological evaluation of medical devices;
- EN ISO 15223-1 on symbols supplied with medical devices;
- EN 60601-1 and EN IEC 60601-2-83 on medical electrical equipment;
- EN ISO 1135-4 and EN ISO 1135-5 on transfusion equipment;
- the EN ISO 15883 series on washer-disinfectors;
- standards concerning ophthalmic optics, mammary implants, prosthetics and sharps injury protection.
Harmonised standards remain a central tool for manufacturers because conformity with the relevant standards, or the applicable parts of those standards, provides presumption of conformity with the MDR requirements they are intended to cover once their references have been published in the Official Journal.
For manufacturers, the practical impact is clear: standards strategies should not be treated as a static element of technical documentation. They require active monitoring, documented gap assessment and controlled implementation through the quality management system.
The Decision also establishes transition periods for the withdrawal of certain previous references. The former references for EN ISO 10993-23, EN ISO 10993-12, EN ISO 10993-17 and EN IEC 60601-2-83 will remain applicable until 15 December 2027. For EN ISO 15223-1:2021, the withdrawal is deferred until 15 June 2031, reflecting the significant operational impact associated with implementing labelling changes.
Manufacturers should assess whether the newly published or amended references affect their devices, processes or existing evidence base. A structured standards impact assessment should consider:
- applicable General Safety and Performance Requirements;
- biological evaluation and risk management documentation;
- verification and validation evidence;
- labelling, symbols and information supplied by the manufacturer;
- electrical safety and essential performance requirements;
- technical documentation updates;
- supplier and manufacturing process impacts;
- change control and transition planning.
DQS recommends documenting the rationale for standard applicability, non-applicability and transition decisions. Where a previous reference is scheduled for withdrawal, manufacturers should establish a documented implementation plan that considers testing needs, technical documentation updates, labelling changes and notified body coordination.
Read Commission Implementing Decision (EU) 2026/1231 in the Official Journal of the European Union.