European Clinical evaluations with In Vitro Diagnostics are now governed by the In Vitro Diagnostic Regulation 2017/746 + update 2023/607
- 5 feb
- 1 minuten om te lezen
Replaced Directive 98/79/ECThe IVDR fully replaces the previous IVD Directive 98/79/EC and introduces a stricter, harmonised regulatory framework for all in vitro diagnostic devices in the EU.
Risk-Based Classification (Class AāBāCāD)The old Annex II listing system is replaced by a new rule-based classification:
Class A:Ā lowest risk
Class B and C:Ā moderate to high individual risk
Class D:Ā highest individual and public health riskMost devices now require notified body involvement.
Clinical Evidence Requirements (Annex XII)Manufacturers must demonstrate:
Scientific validity
Analytical performance
Clinical performanceThis combined evidence is mandatory for conformity assessment.
Clinical Evidence Report (Annex VIII)
All supporting data must be summarised in a Clinical Evidence Report that integrates scientific validity, analytical data, and clinical performance. It must be kept up to date throughout the device lifecycle.
Recording and Reporting of Events
The IVDR strengthens vigilance rules. Serious incidents and corrective actions must be recorded and reported within defined timelines, supported by robust post-market surveillance.
New Definitions
The regulation introduces clearer and expanded definitions for IVD devices, companion diagnostics, performance studies, economic operators, and the Person Responsible for Regulatory Compliance (PRRC).
The IVDR is into force since 26 May 2022.
Ā
EU Regulation 2023/607, which amends EU Regulation 2017/746, allows devices that have been placed on the market before or during the transitional period and are still in the supply chain to be further made available on the market.
Plan ahead to ensure compliance for IVDās currently under development and donāt forget that this legislation will also be applicable to your current and historic products.
