Course overview

Much has changed since the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) were adopted in May 2017.

This course will bring you fully up-to-date on:

the rephrased implementations
the new guidelines
role and output from the Medical Device Co-ordination Group (MDCG)
recent medical device regulatory developments in the UK

It will also consider future developments and the evolving role of the EMA.

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.

Benefits of attending

This is a must-attend workshop and has been designed for all those working or interested in the medical device and diagnostic market in the EU and the UK.

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

Who should attend

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

Enrol or reserve

The A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK 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 Notified Bodies/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

Enrol or reserve

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.

More details

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

22 October 2024

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 14382

GBP 549 649
EUR 789 929
USD 893 1,049

Until 17 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

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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.