2024-07
Please find below an overview of all documents related to the MDR and IVDR amendments, Regulations (EU) 2023/607 and (EU) 2024-1860.
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MDR/IVDR amending Regulations:
- Regulation (EU) 2023/607 and the Q&A
- Regulation (EU) 2024/1860 and the Q&A
MDD/MDR related documents:
- Manufacturer Declaration related to (EU) 2023/607
- Notified Body Confirmation Letter related to (EU) 2023/607
IVDD/IVDR related documents:
- Manufacturer Declaration related to (EU) 2024/1860
- Notified Body Confirmation Letter related to (EU) 2024/1860