Harmonised standards play a crucial role in ensuring compliance with regulatory requirements. To this end, the Commission collaborated with the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) to revise existing standards and to develop new standards pertaining to the sterilization of various medical devices and diagnostics.

The Commission has incorporated the proposed standards into two implementing decisions. The first decision ((EU) 2024/817) adds three sterilization-related standards to an existing annex within the IVDs regulatory framework ((EU) 2021/1195). The second decision ((EU) 2024/815) extends this by incorporating sterilisation standards into an existing decision on medical devices ((EU) 2021/1182), together with additional guidance on, inter alia, medical gloves, packaging for terminally sterilised medical devices and health care products.

Sources:

Commission Implementing Decision (EU) 2024/817 of 6 March 2024

Commission Implementing Decision (EU) 2024/815 of 6 March 2024