This webinar was delivered live on 12th Oct 2017.
The European Commission has recently published the new Medical Device Regulations which introduce new and more extensive requirements on manufacturers, Notified Bodies and other economic operators. Because of the scrutiny and re-designation requirements, we have already seen a significant decrease in the total number of Notified Bodies, leaving many companies looking for new providers. The MDR will be fully implemented by May 26, 2020. MDD certificates can continue to be valid potentially up to May 26, 2024 if the product meets certain conditions. As the transition dates approach, many are concerned there will be a backlog as companies wait until the last minute to try to get device approvals so their device can continue to be sold on the EU market, even for existing products as there will be no grandfathering.
The revised MDR has been modified extensively and under the Regulations. These changes are significant and individuals in companies need to understand the impact of the changes on their job function and product line in order to properly plan and secure resources.
In this 75-minute pre-recorded webinar, UL’s Head of Notified Body, Dr. Itoro Udofia provides a detailed explanation of the new MD regulations and shares his 10 years of industry MDD experience on how to effectively assess the challenge to transition.
Who should watch this video:
- Medical Device Manufacturers
- International Sales
- European Sales
- Regulatory Affairs professionals
- Product Managers
- Product/Development Engineers
- Software Engineers
- Compliance Engineers
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.