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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 well run, met my objectives, and speakers were interesting, approachable and very knowledgeable... more (16)"

30 April 2024
+ 22 October 2024 »

from £549

Need help?  Enrol or reserve

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.

More details

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.

 

More details

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

30 April 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 14381

  • GBP 549 649
  • EUR 789 929
  • USD 893 1,049

Until 26 Mar

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Not ready to book yet?

for 7 days, no obligation

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

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.

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


Very well run, met my objectives, and speakers were interesting, approachable and very knowledgeable.

Sep 24 2019

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

  • Baxter
  • Becton Dickinson
  • Bedfont Scientific Ltd
  • Besins Healthcare
  • Blue Reg
  • Bristows LLP
  • Industrial Technology Systems Limited (ITS)
  • Johnson & Johnson Medical Ltd.
  • Kimberly-Clark Europe Ltd
  • Latham & Watkins LLP
  • MAGSTIM CO LTD
  • Magstim Company Ltd.
  • Medtrade Products Ltd
  • Mundipharma International Services Ltd
  • NDA Regulatory Science Ltd
  • Norgine Ltd
  • Occuity Limited
  • Pioneer Regulatory Limited
  • Precipio Consulting
  • Presspart
  • Proctor & Gamble Technical Centres Ltd
  • SGR Consulting Services Ltd
  • Sinclair Pharma Plc
  • Smart Process Solutions Ltd.
  • sphere medical ltd
  • Torbay and South Devon NHS Foundation Trust
  • Vision RT Ltd
  • Vyaire Medical Products
  • Xiros
  • Xiros Ltd

Germany

  • Bayer Pharma AG
  • Edwards Lifesciences
  • Grunenthal GmbH

Croatia

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Croatian Agency for Medicinal Products and Medical Devices

Denmark

  • Cook Medical
  • LEO Pharma A/S

Netherlands

  • BioTop Medical
  • Keystone Europe BV

United States of America

  • Genentech/Roche
  • Sanofi

Belgium

  • Halyard Health

Costa Rica

  • TQE Consulting SRL

Cyprus

  • Medochemie ltd

France

  • Vexim SA – Stryker IVS

Iceland

  • Primex

Italy

  • Angelini Pharma S.p.A.

Norway

  • LYFSTONE AS

Romania

  • Ewopharma AG

Saudi Arabia

  • Saudi Food and Drug Authority

Switzerland

  • Geistlich Pharma

Enrol or reserve

Run A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 1,299
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy