Presented by
Management Forum

New Medical Device Regulation

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

12-13 Apr 2022 + 2 more dates

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  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

Course overview

During a period of great uncertainty and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare for these changes and operate successfully in Europe. The programme will provide in-depth coverage of the new regulations and how they will be implemented by member states and Notified Bodies. You will hear the latest thoughts on clinical development, safety monitoring, the role of authorised representatives, economic operators, and the implications of Brexit.

There will be plenty of opportunities to discuss the implications of the changes with our expert faculty, and you will gain valuable guidance on successful implementation of the regulatory changes for your company products.

This is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Who should attend

  • Regulatory affairs
  • Clinical studies
  • Vigilance
  • PMS
  • Quality systems
  • Technical support and business development.

Why you should attend

The seminar will provide key guidance and interpretation of the changes to the regulations and will be of value to all those who are involved with placing a medical device on the market, and anyone who requires an essential overview of the new MDR and its impact on the industry and working practices.

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The New Medical Device Regulation course will cover:

Introduction and background to the new regulation

  • Medical Device Coordination Groups
    Dr David Jefferys

Successful implementation of the MDR

  • Managing the urgency – time and resources are tight
  • What you really need to know – how to meet the key requirements
  • Clinical evidence – don’t underestimate its importance
  • The B word (Brexit)
    Peter Rose

Notified Bodies: how the changes will impact NBs and manufacturers – including the new rules for IVD conformity assessment

  • Accreditation and designation of NBs
  • How to register with NBs
  • Conformity assessment applications 
    Theresa Jeary

Increased vigilance and post-market surveillance − how to comply

  • Post-market surveillance systems appropriate for your device and risk classification
  • Periodic safety update reports (PSURs)
  • Manufacturers’ response times to serious public health threats and deaths caused by devices
    Dr David Jefferys

IVDs and companion diagnostics Implications and timelines

  • Implications and timelines
  • New IVD conformity assessment rules 
    Theresa Jeary

Clinical investigations − what is required?

  • Greater protection for patients participating in clinical investigations
  • Products to have an acceptable benefit to risk ratio
  • Product safety and performance
  • Changes in data requirements
  • Restrictions by individual member states
    Janette Benaddi

Other essential considerations

  • Authorised representatives – increased responsibilities and requirements
  • Single registration numbers for all economic operators
  • New categories
  • Single-use devices – reprocessing?
  • Unique device identification
  • Safety and clinical performance summaries
  • Strategies to address the new requirements
    Dr David Jefferys

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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.

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Theresa Jeary

Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. Theresa has over 25 years’ 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 Notified Body experience working at BSi as a technical expert and until January 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 now works as a consultant to the Pharmaceutical and Medical device sectors and is a frequently invited speaker on medical device legislation and combination products.

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Janette Benaddi

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles.

She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

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Book New Medical Device Regulation Live online/Classroom training

12-13 Apr 2022

Live online

08:30-17:00 UK (London) (UTC+01)
09:30-18:00 Paris (UTC+02)
03:30-12:00 New York (UTC-04)
Course code 11581

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 08 Mar

In your basket 

11-12 Jul 2022

Classroom
London venue TBC

08:30-17:00 UK (London)
Course code 11406

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 06 Jun

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

13-14 Oct 2022

Live online

08:30-17:00 UK (London) (UTC+01)
09:30-18:00 Paris (UTC+02)
03:30-12:00 New York (UTC-04)
Course code 11726

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 08 Sep

In your basket 

Reviews of IPI's New Medical Device Regulation 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

UK

  • 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

Italy

  • Angelini Pharma s.p.a.

Norway

  • LYFSTONE AS

Romania

  • Ewopharma AG

Saudi Arabia

  • Saudi Food and Drug Authority

Switzerland

  • Geistlich Pharma

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Multiple colleagues?
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
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy