EU Updates MDR and IVDR
Regulation (EU) 2024/1860 amending the MDR and the IVDR was published in the Official Journal of the EU on 9 July and entered into force immediately.
Important changes include:
- Extension of the transitional provisions of the IVDR according to a tiered approach based on risk classes with the establishment of conditions modelled on Regulation (EU) 2023/607
- Introduction of a notification requirement in the event of interruption of supply of a medical device or in vitro diagnostic medical device
- Gradual introduction of centralised registration in EUDAMED (starting at the end of 2025)
Source:
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