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.
The 60-minute webinar was delivered live on 7th November 2017, UL's Head of Notified Body, Dr. Itoro Udofia, shared his experience on what exactly has changed, what that means for device manufacturers, and how the Notified Bodies will approach the updated requirements.
Who should watch this pre-recorded webinar:
- Medical Device Manufacturers
- International Sales
- European Sales
- Regulatory Affairs professionals
- Product Managers
- Compliance Engineers
- Clinical Research Associates
Register to view the recording:
Dr. Itoro Udofia, Head of Notified Body, UL
Itoro has over fifteen years' experience working with medical devices, including nearly ten years Notified Body experience. Itoro is the new Head of Notified Body at UL, and worked previously for nine years in the BSI Notified Body, as a Product Expert, Global Head of Orthopaedics and Dentals Devices, and Head of Operations and Training.
Itoro has a background in academia and research in biomedical engineering, , and has worked as a research consultant with leading orthopaedic manufacturers in product development and testing. Itoro has authored and published numerous scientific papers and has delivered numerous presentations and workshops at international conferences on European medical device regulations.
Itoro's qualifications include: BEng (Hons.) Biomedical Engineering, and a PhD in Biomedical Engineering and Computational Modelling. He is a past visiting Professor at Wuhan University of Science and Technology in China.