In-Vitro Diagnostic Medical Device Regulation
Key Facts:
- Expanded scope to include companion diagnostics
- Classification systems has been altered to risk-based system to more closely match other international markets
- All non-EU based manufacturers are obligated to appoint an Authorized Representative
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The most extensive and up-to-date database on European IVDR laws. Have a look!
Learn More:
- Scope
- The Regulation: IVDR 2017/746/EU
- Classification
- Technical Documentation
- Path to EU Market Entry: Conformity Assessment Procedures
- Notified Bodies under the IVDR
- Authorized Representatives under the IVDR
- Clinical Evidence and Performance Evaluation
- Clinical Performance Studies
- Person Responsible for Regulatory Compliance
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