EU IVD Regulation (IVDR) | MDV-Solve
About IVDR Compliance
The In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) introduces major changes in the regulatory framework for IVDs. Manufacturers must update their technical documentation and quality systems to comply.
Our IVDR services:
- Gap analysis for IVD devices
- Classification support under IVDR
- Performance evaluation plan and report
- Post-market performance follow-up (PMPF)
- Technical documentation file preparation
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