The clinical evaluation is an essential part of the technical documentation, which manufacturers are required to use to document their compliance with the general safety and performance requirements. The new medical Device Regulations places greater emphasis on the use of clinical data to demonstrate compliance with the general safety and performance requirements. And for certain high risk and innovative devices, new processes have been introduced which involve additional scrutiny of the manufacturer’s clinical evaluation.
With the new Medical Device Regulation and 3-year transition, manufacturers need to be prepared now to meet the requirements in place when their device is being assessed for certification. This includes updating processes to make sure documentation for new requirements is in place. In order to avoid rework and time needed for resubmission, it’s critical to start establishing processes that align with the new requirements as soon as possible. With a reduction in the number of Notified Bodies, there may be a wait and grandfathering of existing devices is not allowed.
In this 60 minute session, UL’s Head of Notified Body, Dr. Itoro Udofia, will share his experience on what exactly has changed, what that means for device manufacturers, and how the Notified Bodies will approach the updated requirements.
Date: Tuesday November 7th, 2017
Time: 11 AM – 12 PM Eastern time (GMT -4)
Where: Live online
Who Should Attend:
- Medical Device Manufacturers
- International Sales
- European Sales
- Regulatory Affairs professionals
- Product Managers
- Compliance Engineers
- Clinical Research Associates
To register, click here.