The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonised standards that support compliance with the Medical Devices Regulation (EU) 2017/745 (MDR).
The decision incorporates a wide range of standards covering key aspects of medical device design, manufacturing, safety, and performance, including:
- Biological evaluation of medical devices
- Symbols used in information supplied by the manufacturer
- Medical electrical equipment
- Transfusion equipment for medical use
- Ophthalmic optics
- Non-active surgical implants
- Washer-disinfectors
- Prosthetics and sharps injury protection
Publication of ISO 15223-1:2025
One of the most significant developments introduced by the implementing decision is the publication of ISO 15223-1:2025, Medical devices — Symbols to be used with information supplied by the manufacturer, in the Official Journal of the European Union (OJEU).
The inclusion of this standard is particularly noteworthy as it introduces new and updated symbols for medical device labelling, including the European Authorised Representative (EU REP) symbol. Harmonisation of this standard provides manufacturers with a clear pathway for demonstrating conformity with the relevant MDR requirements related to labelling and information supplied with the device.
Transition Periods and Compliance Deadlines
The implementing decision also establishes the dates on which the presumption of conformity provided by previous versions of the standards will cease. Manufacturers will therefore need to transition to the newly harmonised versions within the specified timeframes.
The deadlines vary depending on the standard concerned, with transition periods extending from 2027 through to 2031. Notably, ISO 15223-1:2025 has one of the longest transition periods, with compliance required by 2031, providing manufacturers with additional time to update their labelling, packaging, and accompanying documentation to incorporate the revised symbol requirements.
Key Takeaway
Implementing Decision (EU) 2026/1231 represents an important update to the MDR harmonised standards framework. Manufacturers should review the newly listed standards and assess their impact on existing products and quality management systems. Particular attention should be given to ISO 15223-1:2025, as its harmonisation introduces updated labelling requirements, including the EU REP symbol, and will require a planned transition before the 2031 deadline.
The full implementing decision can be accessed using the following link
