Overview Of In Vitro Diagnostic Regulation (IVDR)
TEuropean 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 eg:
Expertise
Advantages of In Vitro Diagnostic Regulation (IVDR)
- Cost-effective
- End-to-end Regulatory consultation, of 510(k) Submission Process Consulting, 513(g) Submission Process Consulting, Clinical Evaluation Report (CER), Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and Performance Evaluation Report (PER)
- Qualified team of experts with hands-on experience across all categories of Medical Devices.
- Expert support for region-specific Regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach to ensure quick product launch or market access
