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.

24-25 Sep 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

The New Medical Device Regulation (MDR) brings about a period of great change, uncertainty and opportunity within the medical technology and diagnostics sectors. This seminar will help you embrace these changes and operate successfully in the new environment in Europe. It will cover in depth the new regulations and their implementation by the Member States and Notified Bodies. You will get to hear the latest thoughts on clinical development, safety monitoring and the implications of Brexit.

Who should attend

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

Why you should attend

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

Programme Day One

Introduction and background to the new regulation

  • Medical Device Co-ordination Groups
    Dr David Jefferys

Key preparation for successful implementation

  • Where, what, how?
  • A road map for the new regulation
  • EUDAMED database – maximising the potential
  • Implications of Brexit
    Oliver Bisazza

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

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

Programme Day Two

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
  • New IVD conformity assessment rules
    Theresa Jeary

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

Panel discussion and key take-home messages

Presenter

Janette Benaddi

Janette Benaddi is an Independent Consultant and previously the Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.

Janette has over 20 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.

Janette is a registered nurse, 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.

Book now

24-25 Sep 2019
24-25 Sep 2019 DoubleTree by Hilton London-West End, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Bayer Medical Care BV
  • Bayer Pharma AG
  • Biotop Medical
  • Blue Reg Europe
  • Bristows LLP
  • Cook Medical
  • Croatian Agency for Medicinal Products and Medical Devices
  • Ewopharma AG
  • Geistlich Pharma
  • Grünenthal GmbH
  • Industrial Technology Systems Limited (ITS)
  • Johnson & Johnson Medical Ltd.
  • Keystone Europe BV
  • Kimberly-Clark Europe Ltd
  • Latham & Watkins
  • LEO Pharma A/S
  • LYFSTONE AS
  • Magstim Company Ltd.
  • Medochemie ltd
  • Medtrade Products Ltd
  • Mundipharma International Services Ltd
  • NDA Regulatory Science Ltd
  • Precipio Consulting
  • Presspart
  • Proctor & Gamble Technical Centres Ltd
  • Sanofi Aventis Deutschland GmbH
  • sphere medical ltd
  • Vexim SA – Stryker IVS
  • Vision RT Ltd

Good, complete coverage of the new regulations. Good anticipating on discussed items.

Marcel Steenhof, Toxicologist and Regulatory Affairs Profesisonal, Keystone Europe BV

[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

Excellent speakers

Iva Ujevic, Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Excellent speakers

Iva Ujevic, Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Very good.

Marie-Cécile Lerat, RA Manager MPS Europe, Becton Dickinson

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

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

Excellent, both content and speaker line up

Zinovia Chatzidimitriadou, Associate, Bristows LLP

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

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

Great content

Andrew Whitton, , Medtrade Products Ltd

Good interactions and good speakers

Katja Gauci, Device Quality Engineer, Mundipharma International Services Ltd