Presented by
Management Forum
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.
★★★★★ "Very good course."
30 April 2025
+ 21 October 2025 »
from £649
Stay informed on the significant changes since the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), adopted in May 2017.
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) in May 2017, 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:
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.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
This training course has been designed for all those working or interested in the medical device and diagnostic market in the EU and the UK, including medical device and in-vitro diagnostic professionals from the following areas:
30 Apr 2025
21 Oct 2025
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.
30 Apr 2025
21 Oct 2025
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.
30 Apr 2025
21 Oct 2025
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.
30 Apr 2025
21 Oct 2025
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.
21 Oct 2025
Steve joined ABHI as Director of Diagnostics Regulation in 2020.
After completing his degree in Biochemistry and Biology at Aston University, Steve trained as a Biomedical Scientist, working in hospital microbiology before moving to industry to work as company microbiologist. Steve joined MHRA in 1996 when it was still the Medical Devices Agency and when the IVD Directive had yet to be implemented.
While at MHRA, Steve worked with manufacturers, Notified Bodies, other Competent Authorities, Trade Associations, standards bodies and government departments. Steve was Chair of the European Commission’s IVD working group when the IVD regulations where being developed.
In 2019, Steve was presented with the TOPRA award for regulatory excellence.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
30 April 2025
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 14658
Until 26 Mar
Not ready to book yet?
for 7 days, no obligation
21 October 2025
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15023
Until 16 Sep
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Very good course.
Oct 22 2024
Richard Jones
Senior Medical Device Auditor, Eurofins E&E CML Limited
Sep 24 2019
Very well run, met my objectives, and speakers were interesting, approachable and very knowledgeable.
Lucie Green
QA Manager, Vyaire Medical Products
Mar 6 2019
Excellent training performed by very knowledgeable speakers.
Marie-Pierre Hontas
Senior Director Scientific & Clinical Affairs, Vexim SA – Stryker IVS
Sep 24 2019
Management Forum have become my go-to provider of life science training. They always find excellent speakers who present their subject matter in a very knowledgeable, complete and thoroughly enjoyable way. I have always found Management Forum courses to be excellent value for money and the New Medical Device Regulation course was no exception.
Stephen Matthews
Validation Consultant, Smart Process Solutions Ltd.
Sep 24 2019
A relaxed, open forum where you felt comfortable to ask any questions you needed through the presentations and the day. The speakers were all very clear, concise, factual and interactive.
Holly Widnall
Project Manager, Bedfont Scientific Ltd
Sep 24 2019
The speakers were very professional and knowledgeable. They delivered the content in an easy format and allowed plenty of time for questions and interaction from the attendees. I particularly liked the section regarding the context of the regulation and background to its development which will help me when explaining this to my clients.
Stephen Rowe
Managing Director, SGR Consulting Services Ltd
Sep 25 2018
[The speakers were] all very knowledgeable. The whole course was very reassuring with the 'big monster' of the MDR being broken down so that it appears manageable and less scary. It was full of helpful advice both general and specific to my products.
Samantha Workman
ISO Manager, Torbay and South Devon NHS Foundation Trust
Sep 25 2018
Good, complete coverage of the new regulations. Good anticipating on discussed items.
Marcel Steenhof
Toxicologist and Regulatory Affairs Profesisonal, Keystone Europe BV
Feb 26 2018
Excellent speakers
Iva Ujevic
Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Feb 26 2018
Excellent speakers
Iva Ujevic
Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Feb 26 2018
Very good.
Marie-Cécile Lerat
RA Manager MPS Europe, Becton Dickinson
Sep 26 2017
This was an excellent introduction to the Medical Device Regulation, focussing on the key changes and considerations to prepare for compliance with the new requirements. The experienced speakers provided much needed guidance and expertise.
Kate Cole
Regulatory Affairs Manager, Xiros Ltd
Sep 26 2017
Excellent, both content and speaker line up
Zinovia Chatzidimitriadou
Associate, Bristows LLP
Sep 26 2017
The speakers were very knowledgeable and lovely people and on the forefront of the devices industry. The presentations were very clear and interactive. The course was excellent and I would highly recommend to anyone wanted to learn about the new MDR.
Daniel Terzian
Project Assistant, NDA Regulatory Science Ltd
Feb 8 2017
Great content
Andrew Whitton
Medtrade Products Ltd
Feb 8 2017
The speakers all did a great job, they were committed and inspiring.
Dorte Reland
Director, PV Operations, LEO Pharma A/S
Feb 8 2017
Good interactions and good speakers
Katja Gauci
Device Quality Engineer, Mundipharma International Services Ltd
United Kingdom
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2 days
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: