Overview Of In Vitro Diagnostic Regulation (IVDR)
European In Vitro Diagnostic Regulation (IVDR) is set to replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).
The first step is to determine if the product is a medical device as defined by the Directive. The In Vitro Device Directive Article 1, point 2b defines an IVD as any medical device, e.g.:
- Reagent, Reagent Product
- Calibrator, Control Material
- Kit
- Instrument, Apparatus
- Equipment, System
Expertise
- Dedicated experts’ team to support post-market surveillance (PMS)
- Gap Analysis of IVDR General Safety and Performance Requirements
- Clinical Performance Reports based on literature
- Post Market Performance Follow-up (PMPF) protocols and Reports
- Post Market Surveillance (PMSR) Protocols and Reports
Advantages of IVDR
- Cost-effective
- End-to-end Regulatory consultation covering 510(k), 513(g), CER, MDR, IVDR, and PER
- Qualified team with hands-on experience across all categories of Medical Devices
- Expert support for region-specific regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach for quick product launch or market access
