European Commission Publishes New MDR Harmonized Standards: Direct Impact on Medical Device Compliance
European Commission Implementing Decision (EU) 2025/681, published on April 9, 2025 in the Official Journal of the European Union, officially updates the Annex to Implementing Decision (EU) 2021/1182, adding six new harmonized standards in the context of Regulation (EU) 2017/745 on Medical Devices (MDR).
These standards, developed by CEN (European Committee for Standardization), reflect the latest technical and scientific advances, responding to a formal request from the European Commission. Their inclusion offers manufacturers a clear way to demonstrate compliance with the essential requirements of the MDR through the legally recognized presumption of conformity.
Areas Covered by the New Harmonized Standards
The new standards now integrated address three critical areas with a direct impact on the safety and performance of medical devices:
1. single-use medical gloves
These standards are especially relevant for manufacturers who produce medical consumables used in clinical and hospital settings:
EN 455-1:2020+A2:2024 - Requirements and tests for hole detection;
EN 455-2:2024 - Requirements and tests for physical properties (strength, elongation, etc.).
2. Sterilization of Medical Devices
Essential for manufacturers whose devices require guarantees of sterility, whether by terminal or aseptically controlled processes:
EN 556-1:2024 - Requirements for terminally sterilized devices;
EN 556-2:2024 - Requirements for aseptically processed devices.
3. Ambulance Patient Transportation Equipment
With a direct impact on the manufacture of mobile medical emergency systems, such as electric chairs and stretchers:
EN 1865-2:2024 - Power-assisted stretchers;
EN 1865-6:2024 - Motorized (electric) chairs.
What does this update mean for manufacturers?
These standards represent more than just a technical update - they directly influence conformity assessment processes, the structuring of technical documentation, applicable tests and the criteria to be included in risk and performance analysis.
For manufacturers, this means:
Need to review technical documentation and declare compliance with new versions;
Collection of new test data, where applicable;
Updating technical data sheets, labels and instructions for use;
Adequate quality control and production processes.
Failure to apply these harmonized standards does not prevent CE marking, but it does oblige the manufacturer to justify by other means (such as alternative standards or their own methods) that the device meets the applicable requirements of the MDR - which can make the assessment and approval processes longer and more complex.
How can Smart MDR help?
The Smart MDR team is ready to:
Assess the impact of these new standards on your product portfolio;
Supporting the updating of technical documentation in accordance with Class I, IIa, IIb or III requirements;
Advising on the best transition strategy to ensure ongoing compliance;
Follow up communication with the Notified Body, if applicable.
For technical clarifications or support in implementing the new regulatory requirements, contact us.
Access the full document below.
EN: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202500681
