New harmonised standards for medical devices and IVDs

On 9 and 10 April 2025, the Official Journal of the EU published references to standards for medical devices. The standards address conformity of medical gloves for single use, sterilization of medical devices, and patient handling equipment used in ambulances.

MDR: harmonised standards for medical gloves, sterilization, and patient handling equipment used in ambulances

With Commission Implementing Decision (EU) 2025/681, the following standards are harmonised under the Medical Devices Regulation (MDR):

This resulted in the adoption of the harmonised standards EN 455-1:2020+A2:2024, EN 455-2:2024, EN 556-1:2024, EN 556-2:2024, EN 1865-2:2024 and EN 1865-6:2024.

IVDR: harmonised standards for sterilization of certain medical devices

With Commission Implementing Decision (EU) 2025/679, the following standards are harmonised under the In-Vitro Diagnostic Medical Devices Regulation (IVDR):

This resulted in the adoption of the harmonised standards EN 556-1:2024 and EN 556-2:2024.

References to harmonised standards are available on the European Commission’s website.

Do you have questions on compliance of medical devices and IVDs? Contact us here or at mdlaw@obelis.net.