Industry Outlook & Insights
Regulatory, Quality and Good Manufacturing Practices
It's now September 2019 and MEDDEV 2.7/1 Rev. 4 is mandatory and EU MDR is right around the corner. Notified bodies are scrutinizing clinical data more than ever and giving companies significant findings for their CERs and, in some cases, refusing to certify products with gaps in clinical evidence, incomplete PMCF, and poorly written CERs. Attendees will come away with an understanding of the latest developments in CERs based on real-life stories. These are case studies you’ll want to hear.
This session will feature medical device manufacturers and device consultants who have created Rev. 4 and MDR compliant CERs for products in a wide range of clinical specialties - being submitted to a variety of notified bodies. Our panel has seen it all and will share the most impactful lessons learned from every aspect of the CER process.
Our speakers have encountered plenty of obstacles…and found solutions. In this session, learn how other manufacturers and experts have addressed closing their CER gaps and achieving compliance. Attendees can take these lessons back to your companies to gather the support needed to get your CERs ready.
Industry leaders will discuss lessons learned and case studies featuring a multitude of challenges. For example:
*What is the difference between a Rev 4 and MDR complaint CER?
*Notified Bodies will review your submission as if it is the first time; what does that mean?
*What are you options if you have a low-risk device with no clinical data?
*How are notified bodies reviewing CERs? What questions are they asking and what are they looking for in the clinical data?
*When do you need to propose pro-active PMS or PMCF?