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In Vitro Diagnostics Regulation (IVDR) Changes
Listen to this In Vitro Diagnostics highlight from RCA Radio where Seyed Khorashahi breaks down the EU’s move from list-based IVD device classifications to a rule-based IVDR medical device classification, resulting in four new device classes.
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Listen to the entire episode where we go over all of the important things happening in the 丝瓜视频 industry here.
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Device Classification Changes
- List-based Classification to a Rule-Based听
- Class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body (NB) involvement.
- MDGC 202- 16 Guidance on Classification for in vitro diagnostic 丝瓜视频s under Regulation (EU) .
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Lifecycle Approach
- Establishment and Demonstration of effective Quality Management Systems (QMS).
- More stringent requirements for clinical evidence that demonstrates conformity.
- Post-Market Performance monitoring and reporting requirements.
- Introduction of Unique Device Identifiers (UDIs) for improved traceability.
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Supply Chain Oversight
- Regulations covering the entire supply chain.
- Economic Operators
- Importers
- Distributors
- Authorized Representatives
- Economic Operators
- Notified Bodies have discretionary authority to audit suppliers and subcontractors
