Course overview
Stay informed on the significant changes since the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR).
The landscape of medical device and in-vitro diagnostic regulations in the EU and UK has undergone significant transformation in recent years. With the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR),, the regulatory framework has become more rigorous and complex. Staying abreast of these changes is crucial for professionals involved in regulatory affairs, quality assurance, and related fields to ensure compliance and maintain market access.
This course is essential for those seeking to stay fully updated on the latest regulatory developments.
Key topics to be addressed:
- Comprehensive insights into the rephrased implementations of MDR and IVDR
- Understand the new guidelines
- Learn about the role and output of the Medical Device Coordination Group (MDCG)
- Recent medical device regulatory developments in the UK, providing a comparative perspective on the evolving regulatory landscape
- Explore potential future developments and the evolving role of the European Medicines Agency (EMA) in the context of medical device regulations
This course offers a unique opportunity to hear from regulatory experts, discuss the implications of current and forthcoming regulations on working practices, and understand the potential impact on future regulatory strategies.
This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.
Please note: This programme has been designed to reflect the most current understanding of the regulatory landscape for medical devices and IVDs. The content will be delivered using the latest available information at the time of presentation, adapting to any regulatory developments that emerge beforehand. Attendees can expect a clear overview of current requirements, insight into forthcoming regulatory changes, and informed discussion of future developments, including evolving controls on software, AI-supported devices, and healthcare applications.
CPD Hours: 6
Course Content
- Day 1
- Overview of the current position with the EU MDR
- European view from industry - medical devices
- European view from industry - IVD
- General update on the UK MDR
- Update on the UK MDR proposals including PMS SI and IVDs
- Notified Bodies (NBs) & Conformity Assessment Bodies (CABs) - update on progress from an NB perspective
- Combination products
Speakers
David Jefferys
Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20 years as a senior regulator for both medicines and medical devices.
He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI, EFPIA and IFPMA.
Ian Sealey
Ian Sealey graduated with a BEng (Hons) in Medical Engineering in 2003 and, after a taking a year out to study for a Graduate Diploma in Law, held health-related engineering and policy roles in the private sector, local government, and the National Health Service.
In 2012 he joined the Civil Service as a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency and, in 2015, was appointed assistant secretary at the Department of Health, with responsibility for running its Departmental Board.
Since leaving the Civil Service in 2017 he has provided regulatory, quality, technical, and policy consultancy services to multinational and start-up medical device and in vitro diagnostic medical device manufacturers. His specialist interests include the risk management of electromedical devices, multi-legislative CE marking, and training delivery.
Sue Spencer
Sue Spencer BSc (Hons) is Head IVD, Principal Consultant and UK Country Manager.
Sue leads Qserve’s IVD service, she has over 37 years’ experience in the Medical Device and IVD industries including extensive notified body experience.
Key areas of expertise include
· IVDD and IVDR regulations and transitions
· UKCA
· QMS implementation
· Internal, supplier and compliance audits
· Risk Management
· CDx
· Training
· Working with small start-up and multinationals
· Notified Body interaction
Sue has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing, and quality assurance. Sue worked for 3 notified bodies establishing two from scratch.
Sue has worked for Qserve for 4 years helping manufacturers transition to the IVD Regulation and leading a team specialising in both European and FDA submission and quality systems, with special interests in CDx.
Theresa Jeary
Theresa Jeary is Principal Technical Specialist, Medicinal and Biologics, with BSi.
Theresa holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. She has over 25 years of experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been involved in the development of many commercially available medicinal and medical device products.
She has over 10 years of Notified Body experience working at BSi as a technical expert and previously held the position of Head of Notified Body at LRQA. Her area of technical expertise is in device-drug combinations and borderline classifications, and she has completed many successful consultations in this area with many European Competent Authorities and EMA.
Theresa is a frequently invited speaker on medical device legislation and combination products.
