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Management Forum

A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course

Where are we now and the future developments in the EU 27 and the UK

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 £549

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Format: Live online
CPD: 6 hours for your records
Certificate of completion

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Course overview

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:

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 is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of attending

Stay updated on MDR and IVDR implementations, new guidelines, and recent UK regulatory developments
Explore the changes in the UK regulation as its system becomes independent and moves away from the EU rules
Navigate the increasingly complex world of device and diagnostic regulations
Gain insights into future changes to the regulations and how "digital medicine" may be regulated in the future
Learn from leading regulatory experts and gain practical advice

Who should attend?

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:

Regulatory affairs
Clinical studies
Vigilance
Post-market surveillance
Quality systems
Technical support and business development

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This course will cover:

Welcome and introduction

New features
Key roles
Key learnings

Overview of the current position with the MDR

Where are we today?
How have we got to this point
The evolution of ‘Digital Medicine’ and its impact on the MDR

EU view from industry - medical devices

What has been delivered
What remains outstanding
How will things progress
Challenges and opportunities
Notified bodies and QMS

View from industry - IVDs

What has been delivered
What remains outstanding
How will things progress - what are the transitional arrangements and how best to use them
Challenges and opportunities
Notified Bodies and Quality Mangement Systems (QMS)

Notified Bodies (NBs) and Conformity Assessment Bodies (CABs) - Update on progress from an NB perspective

How many NBs/CABs are there?
Role of the Medical Device Co-ordination Group (MDCG)
Nando (New Approach Notified and Designated Organisations) Information System
Implications of the MDR, Brexit and the Covid Pandemic
UK Approved Bodies/CABs
Differences and similarities between Notified Bodies and UK Approved Bodies
How is the Conformity Assessment process working

Combination products

EU pharmaceutical products influence
New role of the European Medicines Agency (EMA) / Committee for Medicinal Products for Human Use (CHMP)
Implications of MDR:Article II7

UK regulatory proposals for medical devices and IVDs

IDAP and innovation in the UK
MHRA roadmap for international recognition and domestic legislation
MHRA roadmaps for AI/SaMD and IVDs
UK regulations on post-market activities

Panel discussion

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David Jefferys
Eisai

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.

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Ian Sealey
Vertexian

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.

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Sue Spencer
Qserve Group UK, Ltd

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.

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Theresa Jeary
BSI

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.

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Stephen Lee
ABHI

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.

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NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

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

GBP 549 649
EUR 789 929
USD 893 1,049

Until 26 Mar

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

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

GBP 549 649
EUR 789 929
USD 893 1,049

Until 16 Sep

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

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.

Reviews of IPI's A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK training course

Very good course.

Oct 22 2024

Richard Jones United Kingdom
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 United Kingdom
QA Manager, Vyaire Medical Products

Mar 6 2019

Excellent training performed by very knowledgeable speakers.

Marie-Pierre Hontas France
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 United Kingdom
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 United Kingdom
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 United Kingdom
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 United Kingdom
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 Netherlands
Toxicologist and Regulatory Affairs Profesisonal, Keystone Europe BV

Feb 26 2018

Excellent speakers

Iva Ujevic Croatia
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 Croatia
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 United Kingdom
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 United Kingdom
Regulatory Affairs Manager, Xiros Ltd

Sep 26 2017

Excellent, both content and speaker line up

Zinovia Chatzidimitriadou United Kingdom
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 United Kingdom
Project Assistant, NDA Regulatory Science Ltd

Feb 8 2017

Great content

Andrew Whitton United Kingdom
Medtrade Products Ltd

Feb 8 2017

The speakers all did a great job, they were committed and inspiring.

Dorte Reland Denmark
Director, PV Operations, LEO Pharma A/S