The Harmonized Standards under the MDR and IVDR have been updated: HERE

The following changes were made:

NEW:

‘EN ISO 10993-10:2023: Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021)’ has been newly harmonized standard under the MDR.

MODIFIED:

‘EN ISO 25424:2019: Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018)’, was replaced with the version that includes the amendment: ‘EN ISO 25424:2019/A1:2022’. This change is applicable under both the MDR and IVDR.

Our Knowledge Center page has been updated accordingly: List of EU MDR/IVDR Harmonized Standards & Common Specifications