European Commission Updates EU MDR Harmonized Standards List

Published: 17 June 2026

The European Commission has published Commission Implementing Decision (EU) 2026/1231, introducing important updates to the list of harmonized standards supporting compliance with Regulation (EU) 2017/745 on Medical Devices (EU MDR).

Harmonized standards play an important role in demonstrating conformity with the applicable requirements of the EU MDR. Manufacturers that apply the relevant harmonized standards benefit from a presumption of conformity with the corresponding requirements covered by those standards. As standards continue to evolve in line with scientific and technological developments, manufacturers should remain aware of updates that may affect their products, technical documentation, testing activities, and regulatory compliance strategies.

The latest decision introduces both new harmonized standards and amendments to existing standards across several medical device disciplines, including biological evaluation, medical electrical equipment, labeling and symbols, transfusion equipment, ophthalmic optics, implants, washer-disinfectors, prosthetics, and sharps injury protection.

Key Standards Added

The Commission has added several important standards to the list of harmonized standards supporting compliance with the EU MDR. These standards cover a broad range of medical device categories and technical disciplines.

The newly harmonized standards include:

• EN ISO 10993-1:2025 – Biological Evaluation of Medical Devices – Requirements and General Principles
• EN ISO 10993-5:2009/A11:2025 – Tests for In Vitro Cytotoxicity
  EN 60601-1:2006/A13:2024 – Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance
• EN ISO 1135-4:2025 and EN ISO 1135-5:2025 – Transfusion Equipment for Medical Use
• EN ISO 14607:2025 – Non-Active Surgical Implants – Mammary Implants
• EN ISO 23908:2025 – Sharps Injury Protection
• EN ISO 15883 Series:2025 – Washer-Disinfectors
• EN ISO 22675:2025 – Prosthetics – Testing of Ankle-Foot Devices and Foot Units
• EN ISO 12870:2025 and EN ISO 14889:2025 – Ophthalmic Optics

These additions provide manufacturers with updated state-of-the-art standards that can be used to demonstrate conformity with applicable EU MDR requirements.

Updates to Existing Harmonized Standards

The decision also introduces amendments to several standards that are already referenced under the EU MDR framework.

The updated standards include:

• EN ISO 10993-23:2021/A1:2025 – Tests for Irritation
• EN ISO 10993-12:2021/A1:2025 – Sample Preparation and Reference Materials
• EN ISO 10993-17:2023/A1:2025 – Toxicological Risk Assessment of Medical Device Constituents
• EN ISO 15223-1:2021/A1:2025 – Symbols to be Used with Information Supplied by the Manufacturer
• EN IEC 60601-2-83:2020/A1:2025 – Home Light Therapy Equipment

Manufacturers currently relying on these standards should review the amendments and assess any impact on their technical documentation, testing activities, and regulatory compliance programs.

Notable Change: ISO 15223-1 Medical Device Symbols

One of the most significant updates relates to EN ISO 15223-1, the standard governing symbols used with information supplied by the manufacturer.

The amendment introduces updates associated with the Authorized Representative symbol and related terminology. While the technical changes may appear straightforward, they can have a broader impact on product labeling, instructions for use, packaging artwork, inventory management systems, and distribution processes.

Manufacturers marketing devices in multiple regions should carefully assess the implications of these changes and determine whether updates to labeling and associated documentation will be required during the transition period.

Impact on Manufacturers

Manufacturers should evaluate the applicability of these standards to both existing and new products. Depending on the device type and applicable standards, the update may affect:

• Biological evaluation and biocompatibility assessment activities
• Risk management documentation
• Electrical safety and performance testing
• Labeling and symbol implementation
• Technical documentation and design dossiers
• Conformity assessment planning
• Regulatory submissions and notified body reviews

Organizations preparing MDR submissions or maintaining CE-marked devices should review these updates and identify any actions necessary to maintain compliance.

Transition Timelines

Manufacturers should take note of the transition periods established by the European Commission.

• The withdrawal of references to most superseded standards will apply from 15 December 2027.
• For EN ISO 15223-1, a longer transition period has been provided, with implementation extending until 15 June 2031, recognizing the significant impact of labeling changes across the medical device industry.

Early planning will help manufacturers implement the necessary updates in a controlled and efficient manner.

Conclusion

Commission Implementing Decision (EU) 2026/1231 represents an important update to the EU MDR harmonized standards framework. The inclusion of new standards and amendments reflects ongoing advancements in medical device technologies, testing methodologies, and regulatory expectations.

Manufacturers should review the newly published standards, assess their applicability, and establish appropriate implementation plans where required. Proactive evaluation of these changes can help support continued compliance with EU MDR requirements and facilitate uninterrupted access to the European market.

MedOrdyn Solutions provides regulatory and quality consulting services to medical device manufacturers, supporting MDR compliance, quality management systems, risk management, clinical evaluation, technical documentation, and global market access initiatives..