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

Presenting MDlaw.eu:

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
• Legal Obligations for IVD Distributors

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