The European Commission has recently updated the list of harmonised standards to support compliance with the MDR(EU) Regulations 2017/745 (EU) and IVDR(EU) Regulations 2017/746. Two Implementing Decisions published on April 8, 2025 – 2025/681 for Medical Devices and 2025/679 for in vitro diagnostic Medical Devices – added regulatory references to facilitate compliance with the essential requirements of the European regulations.
The Implementing Decision (EU) 2025/681 amends the annex of Decision (EU) 2021/1182 and includes the following new harmonised standards
Disposable medical gloves:
- EN 455-1:2020+A2:2024 – Part 1: Introduces changes to the requirements and test methods to ensure the integrity of medical gloves and protection from contaminants. Amendment A2:2024 provides further clarifications and specific updates.
- EN 455-2:2024—Part 2 specifies requirements and test methods for the physical properties of medical gloves, such as size, tensile strength, and elongation before and after ageing, to ensure that they retain their functionality during use.
Medical Devices sterilization:
- EN 556-1:2024 – Part 1: Terminal sterilisation; defines the requirements for Medical Devices to be sterilised at the end of the manufacturing process, ensuring a high level of sterility to prevent infection.
- EN 556-2:2024 – Part 2: Specifies requirements for Medical Devices manufactured using aseptic processes, where sterility is maintained during production rather than achieved by terminal sterilisation.
Patient transport equipment used in ambulances:
- EN 1865-2:2024 – Part 2: Assisted stretchers: updates the safety and performance requirements for assisted stretchers used in ambulances, ensuring the safety of both patients and healthcare personnel during transport.
- EN 1865-6:2024 – Part 6: Specifies safety and performance requirements for motorised chairs used to transport patients inside and outside ambulances.
The publication of these updated standards in the Official Journal of the European Union allows medical device manufacturers to benefit from the presumption of conformity with the relevant requirements of MDR (EU) 2017/745. This means that if a manufacturer uses these harmonised standards, their device is presumed to comply with the essential safety and performance requirements set by MDR for the aspects covered by the standards.
In parallel, the Implementing Decision (EU) 2025/679 also introduces regulatory references for in vitro diagnostic devices. Specifically, EN 556-1:2024 and EN 556-2:2024 are also applicable to IVDs that are to be sterilised, facilitating the demonstration of compliance with the relevant requirements of Regulation (EU) 2017/746 (IVDR).
Implications for manufacturers
The adoption of harmonised standards eases the path to compliance, allowing manufacturers to more easily demonstrate compliance with legal requirements. This official announcement through an Implementing Decision means that these standards are now formally recognised at the European level for presumption of conformity. However, it is important to remember that the use of such standards remains voluntary: other means of demonstrating compliance may also be used, provided that they offer an equivalent level of assurance.
The updating of the standards implies that previous versions will be phased out and will no longer provide the presumption of conformity once the transition periods have elapsed. Manufacturers will therefore have to adapt their production processes and technical documentation to refer to the new editions.
Companies in the industry must take note of these updates and assess their impact on their compliance strategies.
>>> Thema supports manufacturers in complying with harmonised standards for MDR and IVDR as part of its strategic regulatory consulting and quality services.
SOURCE:
https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32025D0681
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AL_202500679
