Navigating EU's In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR)
Europe’s In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) in the world’s second-largest medical device market has been effective since May 26, 2022. This new regulation introduces major changes to how IVD manufacturers obtain CE Marking and maintain access to the European market, including a thoroughly revised classification system that will require Notified Body intervention for many formerly self-certifying devices. Our IVDR Resource Center provides information and tools to support IVD manufacturers as they manage and execute their European regulatory transition strategies.
Key IVDR compliance requirements and challenges
Creating an actionable roadmap to IVDR compliance is a complex process. The IVDR introduces new concepts and stricter requirements, including new activities such as clinical data gathering and usability engineering (UE) standards compared to the previous European In Vitro Diagnostic Medical Devices Directive (IVDD), which means manufacturers must now address issues including:
- Risk-based classification that will newly require Notified Body intervention for many IVD types
- Total product lifecycle approach to CE Marking certification
- Enhanced post-market surveillance (PMS) and post-market performance follow-up (PMPF) requirements
- Notified Body capacity: Does your NB plan to obtain IVDR designation, and if so, when?
- Changes to European Authorized Representative (AR) roles and agreements
- Eudamed database submission requirements for manufacturers, devices and other economic operators
Download our IVDR Readiness Checklist to quickly assess your level of compliance with the new regulation and identify next steps.
Emergo by UL consultants are ready to fully support your CE Marking transition from the In Vitro Diagnostic Medical Devices Directive (IVDD) to the IVDR.
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