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.
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.
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 Group - 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
Mr David Jefferys,
Senior Vice President ,
Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine 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, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.
Ms Janette Benaddi,
Director of Clinical & Consulting Europe ,
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 ahs 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.
Ms Theresa Jeary,
Technical Manager for Medical Devices ,
Lloyds Register Quality Assurance (LRQA)
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 a part of the team for many commercially available medicinal and medical device products.
Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.
Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the “fence” and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).
Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.
At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.
Mr Oliver Bisazza,
Oliver Bisazza is Head of the Regulatory Affairs Team at MedTech Europe, Brussels, Belgium: the association representing the medical technology industries in Europe.
In this role, Oliver’s focus is implementation of the EU regulations on medical devices and in vitro diagnostics. He acts as these industries’ main messenger towards the European Commission and Competent Authorities.
Oliver joined MedTech Europe in August 2018 - prior to that, he was Director of Regulatory Policy EMEA at Medtronic.
Venue to be announced shortly.