{"id":35832,"date":"2026-07-29T09:49:44","date_gmt":"2026-07-29T07:49:44","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35832"},"modified":"2026-07-29T12:50:28","modified_gmt":"2026-07-29T10:50:28","slug":"mdr-and-ivdr-the-commission-updates-the-lists-of-harmonised-standards","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2026\/07\/29\/mdr-and-ivdr-the-commission-updates-the-lists-of-harmonised-standards\/","title":{"rendered":"MDR and IVDR: the Commission updates the lists of Harmonised Standards"},"content":{"rendered":"

On 17 June 2026<\/strong>, the European Commission published two Implementing Decisions in the Official Journal of the European Union, updating the lists of references for harmonised standards in support of Regulation (EU) 2017\/745 (MDR) and Regulation (EU) 2017\/746 (IVDR).<\/p>\n

Implementing Decision (EU) 2026\/1231<\/strong><\/a> amends Implementing Decision (EU) 2021\/1182 regarding harmonised standards for medical devices under the MDR<\/strong>. The update spans several technical areas, including biological evaluation of medical devices, symbols to be used in information supplied by manufacturers, medical electrical equipment, transfusion equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics, and protection against sharps injuries.<\/p>\n

Implementing Decision (EU) 2026\/1313<\/a><\/strong> amends Implementing Decision (EU) 2021\/1195 regarding harmonised standards for in vitro<\/em> diagnostic medical devices under the IVDR<\/strong>. Among the updates is the harmonised standard on symbols to be used in information supplied by manufacturers<\/strong>, referencing EN ISO 15223-1.<\/p>\n

Applying a harmonised standard whose reference is published in the OJEU allows manufacturers to benefit from a presumption of conformity<\/strong> with the requirements covered by the standard, provided that reliance on harmonised standards remains voluntary.<\/p>\n

EN 60601-1: among the most significant updates<\/strong><\/h3>\n

A key highlight is the inclusion of the harmonised reference for EN 60601-1:2006\/A13:2024<\/strong>, the general standard for basic safety and essential performance of medical electrical equipment.<\/p>\n

This update was particularly anticipated by manufacturers of medical electrical equipment, who can now rely on the harmonised standard to demonstrate compliance with electrical safety and essential performance aspects covered by the MDR.<\/p>\n

Updated EN ISO 10993 series<\/strong><\/h3>\n

Implementing Decision (EU) 2026\/1231<\/strong> also updates several references in the EN ISO 10993 series, the benchmark for the biological evaluation of medical devices<\/strong>. The updates include new editions and amendments of standards dedicated to biological risk management<\/strong> (EN ISO 10993-1), in vitro<\/em> cytotoxicity<\/strong> (EN ISO 10993-5), sample preparation<\/strong> (EN ISO 10993-12), toxicological risk assessment<\/strong> (EN ISO 10993-17), and irritation testing<\/strong> (EN ISO 10993-23).<\/p>\n

For certain standards – specifically EN ISO 10993-12, EN ISO 10993-17, and EN ISO 10993-23 – the Commission has provided a transitional period until 15 December 2027, allowing manufacturers time to plan for potential adoption of the new versions.<\/p>\n

New Authorised Representative symbol<\/strong><\/h3>\n

The updates also feature EN ISO 15223-1\/A1:2025, which modifies the symbol for the Authorised Representative<\/strong>, introducing a graphical representation no longer tied to a specific country or territory.<\/p>\n

Given the impact on labelling, packaging, and instructions for use, the previous harmonised reference will continue to confer a presumption of conformity until 17 June 2031, granting economic operators ample time to adapt.<\/p>\n

Other standards affected<\/strong><\/h3>\n

The update additionally includes new harmonised references for numerous other standards, including EN IEC 60601-2-83<\/strong> for home phototherapy equipment, the EN ISO 15883 series on washer-disinfectors, EN ISO 14607<\/strong> for mammary implants, EN ISO 23908 for sharps injury protection devices, EN ISO 1135-4 and 1135-5 for transfusion sets, EN ISO 12870 and EN ISO 14889 for ophthalmic devices, and EN ISO 22675 for ankle-foot prostheses.<\/p>\n

Conclusions<\/strong><\/h3>\n

The new Decisions expand the framework of available harmonised standards for the MDR and IVDR. While compliance remains voluntary, utilizing these standards serves as an essential reference for manufacturers, as they reflect the recognized state of the art<\/strong> at the European level and grant a presumption of conformity<\/strong>.<\/p>\n

If a manufacturer chooses not to adopt them, the burden of proof rests entirely on them to demonstrate that alternative solutions meet equivalent safety levels. It is therefore recommended to assess the impact of these new references on the technical documentation of medical devices.<\/p>\n

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