The European Medical Devices Regulation and MDUFA IV:One Year On - Is It Any Clearer?
Angela Stokes, MS
Senior Director, 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 : Assess how your own organization is managing the change to the new EU regulations; Assess what changes the MDUFA IV regulations have already made and how things might change further; Identify areas where your organization still needs to move forward to comply with the new regulations; Interpret the new regulations and guidance to benefit their own working environment.
To be determined
Lloyds Register Quality Assurance (LRQA), United Kingdom
To be determined
LeeAnn L Chambers, MS
Principal Research Scientist, Global Regulatory Affairs, CMC - Devices
Eli Lilly and Company, United States