RAPS Twin Cities Chapter: Clinical Evaluation in the EU for Medical Devices – Changing Expectations

Tuesday, August 22, 2017, 5:30 PM - 8:30 PM CT

Join colleagues from your local regulatory community for an evening of networking and to hear an expert presentation on medical device clinical evaluations in the EU.

MEDDEV 2.7.1 rev 4 was published in June 2016 and the MDR final text was published in the Official Journal of the European Union in May 2017. With these new documents, the requirements with regard to clinical evaluation in the EU have changed significantly. They will lead to clinical investigations being conducted more frequently for CE Marking (probably of larger size than before) and notified bodies will be looking more closely at how all the “essential requirements” (general safety and performance) are met, including those with regard to usability. The CER reports themselves will need to be updated more frequently, written and reviewed by more highly qualified evaluators, and more closely integrated with the various stages of the product lifecycle.

Estimates suggest approximately 20 man-days per CER to update these to the new requirements, which for multi-product organizations, will quickly add up to a large amount of capacity need.  Therefore, it is extremely important to understand the new requirements, and potential strategies for meeting them, to allow for planning in a timely manner to bring your CERs and related QMS processes into compliance.

Specific topics to be covered include:

  • What is MEDDEV 2.7.1 Rev 4 for Clinical Evaluation in EU?
  • What are some of the most significant changes?
  • When does this go into effect?
  • How does this align with the changes to the “MDD” (i.e. the new Medical Device Regulations and In vitro Diagnostic Regulation)?
  • How often must I update my CERs now and what qualifications must the evaluators have?
  • How should I prepare for the increased notified body scrutiny in this area?
  • How do I perform a clinical literature review to meet the new expectations?

This event is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Dinner will be provided. RAC holders may claim two RAC recertification credits.