An understanding of the requirements of the In Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) is essential to maintain market access for your devices. The IVDR brings with it significant changes to the regulatory requirements for IVD manufacturers and introduces a new rule-based classification system with stricter notified body oversight, as well as substantial changes to the depth of the associated documentation.
Key takeaways and learning objectives
- Performance evaluation and for the risk classes C and D the summary of safety and performance (SSP)
- The requirements for State-of-the-art and Post-market performance follow-up (PMPF)
- Post-market surveillance (PMS), including periodic safety update reports (PSUR) for Class C and D devices
- Continual risk acceptability as part of the risk management plan
Dr Möhlig-Zuttermeister has been with BSI since July 2014, overseeing the conformity assessment work including technical documentation assessments under the IVDD and IVDR conducted by the team as well as qualification, training and mentoring of the technical team and conducting final certification decisions according to the IVDD & IVDR.