New update of harmonised standards under the MDR published in the OJEU

The European regulatory framework for medical devices continues to evolve, and with it, the technical standards that underpin compliance with Regulation (EU) 2017/745.

On 17 October 2025 , the European Commission published in the Official Journal of the European Union Implementing Decision (EU) 2025/2078 , which introduces a relevant update to the list of harmonised standards applicable to the MDR.

Key additions include the new 2025 versions of key industry standards, such as EN 13795-1 and EN 13795-2 , relating to cloths, surgical gowns and clean air suits; EN 14683 , which regulates surgical masks; and EN 14180 , focused on sterilizers for medical use.

From the moment of their publication, these rules confer a presumption of conformity with the essential requirements of the Regulation.

This change means that Notified Bodies will begin requiring reference to updated versions within manufacturers' technical documentation, test reports, and quality management systems.

Those still working with previous versions should review their internal procedures to ensure that documentation and performance evidence are aligned with the new edition.

At Belab Services , we recommend that manufacturers and distributors review their list of applicable standards and conduct a gap analysis to plan for a smooth transition. This step is especially relevant for sterile devices and surgical masks, where the update can have a direct impact on performance testing and sterilization process validation.

The publication of this decision confirms the European Commission's commitment to strengthening the safety and quality of medical devices on the European market . In an increasingly demanding regulatory environment, staying up-to-date is key to maintaining compliance and avoiding issues during audits by Notified Bodies.