New harmonised standards under the MDR. The European Commission updates the list of standards by Decision 2026/1231.

What is the new EU implementing decision on harmonised standards, and why is it important for every manufacturer?

Compliance with a harmonised standard is not mandatory under the MDR; a manufacturer may demonstrate compliance with the general safety and performance requirements (GSPR, Annex I to the MDR) by other means. In practice, however, harmonised standards act as a regulatory shield: Article 8(1) of Regulation 2017/745 stipulates that a device which complies with a harmonised standard or the relevant part thereof, the reference to which has been published in the Official Journal of the EU, shall be presumed to comply with the requirements covered by that standard.

For a notified body conducting a conformity assessment, this means a precise, agreed criterion; for the manufacturer, it means the certainty that the correct application of the standard eliminates the need for separate justification in the relevant technical area. Each update to the list is therefore a signal that the Regulatory Affairs and Quality Assurance departments must translate into specific actions within the quality management system and technical documentation.

Decision 2026/1231 amends the previous list set out in Implementing Decision (EU) 2021/1182 and is the result of a standardisation request submitted by the Commission to CEN and CENELEC in 2021. The aim of the review was to take account of the latest scientific and technical progress in the areas comprehensively regulated by the MDR, i.e. from biological evaluation through manufacturer labelling to implantable devices and electrical devices.

Amendments to standards already on the list – what has changed?

The first group of changes concerns five standards that were included in the previous list 2021/1182. Each of them has been amended to specify 2025 as the date; at the same time, the reference to the previous version will be deleted, subject to the reservations regarding deadlines discussed below.

Particular attention should be paid to item 5, concerning the EN ISO 15223-1 standard on symbols used in labelling and instructions for use. Amendment A1:2025 introduces the defined term authorised representative and modifies the EC REP symbol so that it is geographically neutral – it does not refer to a specific country or region.

This change is global in nature and applies to every manufacturer exporting devices both to the EU market and beyond. Precisely because of the scale of this modification and the associated costs of redesigning labels, packaging and printing systems throughout the production and distribution chain, the Commission has provided for an exceptionally long, five-year transition period for this standard.

Fourteen standards included in the MDR list for the first time

The second and more extensive group of changes comprises standards whose references have not yet been published in the OJEU in connection with the MDR. Upon inclusion in the list, they acquire the status of an instrument of presumption of conformity from the date of publication of the decision.

For manufacturers of products in these categories, the granting of harmonised status represents a qualitative change: whilst previously the application of these standards was considered good industry practice or an internal requirement of a notified body, from the date of publication of the decision, their use officially triggers the presumption of conformity with the MDR.

EN ISO 10993-1:2025 deserves special mention; it is a fundamental standard in the biological evaluation process, describing a systematic approach to biological risk management. Its inclusion in the list in the 2025 version means that it is necessary to verify whether the technical documentation and the biological evaluation plan refer to the current edition.

Implementation timetable

Decision 2026/1231 entered into force on the date of its publication (17 June 2026), although the individual provisions have different dates of application:

• from 17 June 2026, the standards listed under items 52–65 (new entries) are presumed to be in conformity with the MDR; manufacturers may rely on them immediately.
• from 15 December 2027, references to previous versions of the standards will be deleted: EN ISO 10993-23:2021, EN ISO 10993-12:2021, EN ISO 10993-17:2023, EN IEC 60601-2-83:2020 and EN ISO 15223-1:2021. Until that date, technical documentation may still refer to versions prior to amendment A1:2025.
• from 15 June 2031, the reference to EN ISO 15223-1:2021 (without amendment A1:2025) will be withdrawn. This is an unprecedented five-year coexistence period for both versions of the standard.

Links to source documents

• Implementing Decision (EU) 2026/1231
• MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices