戻る Agenda
The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer?
Session Chair(s)
Angela Stokes, MSC
Vice President, Head Global Regulatory Consulting
Syneos Health, United Kingdom
2017 was a big year for devices in Europe and US. Last year an overview of the new regulations was presented but it was clear that many questions remained in both US and EU about how the new regulations would affect the way medical devices are manufactured, tested and sold. The transition period in EU is now one year further along…have we had the enabling acts promised? Do they make life easier? What is still missing? Has the confusion been allayed by meaningful guidance? Is your supply chain sufficiently controlled? Are your MAIDs in compliance? In US, how is MDUFA IV shaping the devices market in the US? Have the new FDA user fees for de novo medical device registrations impacted manufacturers’ plans for commercialization of cutting-edge products in the US? Is the reduced fee for small-businesses for de novo applications too high for some prospective US medical device market companies? This session will review what has been seen to date and will consider what may be yet to come as we negotiate the many pitfalls and hurdles facing device manufacture, registration and commercialization in the forthcoming years.
Learning Objective : ACompare how your organization is managing the change to the new EU regulations; Recognize what changes the MDUFA IV regulations have already made and identify what areas may continue to change; ; Identify areas within your organization that need to change to comply with the new regulations; Interpret the new regulations and guidance to benefit individual working environments.
Speaker(s)
Industry Perspective
Theresa Jeary, MSC
Lloyds Register Quality Assurance (LRQA), United Kingdom
Head of Notified Body
Industry Perspective
LeeAnn L Chambers, MS
Eli Lilly and Company, United States
Principal Research Scientist, Global Regulatory Affairs, CMC - Devices