An Introduction to the Medical Device Regulation

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

11-13 Nov 2019

& 13-15 May 2020 , 11-13 Nov 2020

GBP 1,849 1,549 *
EUR 2,589 2,169 *
USD 2,884 2,416 *
* When you book before 4 Oct

Book now

Course Overview

This seminar provides a detailed introduction to the European Medical Device Regulation (MDR). It will explain the new legislation and which products are covered, the involvement of Notified Bodies and how to choose one and will outline a manufacturer’s responsibilities. It will also cover the documentation necessary to apply for the CE mark.

This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.

Who should attend

Past delegates include personnel from regulatory affairs, pharmacovigilance, quality assurance and technical support. This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.

Programme day one

What is a medical device?

  • Definition
  • Examples

Discussion session

Europe and the MDR – overview of the regulations applicable for bringing a medical device to market

Discussion session

Economic operators and other parties

  • Who are they?
  • How do they interrelate?
  • What are their responsibilities?

Classification of devices

  • What are the classes and how do we classify devices?

Discussion session

Conformity assessment procedures

  • The routes to CE marking
  • What is required for each class of device?

Workshop 1: Classification

Discussion session

Programme day two

Manufacturers’ responsibilities

  • Technical file and design dossier requirements

Quality systems

  • EN ISO 13485: 2012 and 2016
  • The requirements for a quality system

Discussion session

Labelling of devices

  • Use of language and symbols
  • Instructions for use

Discussion session

Workshop 2: Labelling

Discussion session

Clinical evaluations

  • European regulatory environment
  • When are clinical investigations necessary?
  • What is required by the Competent Authority, Ethics Committee and Notified Body?

Discussion session

Workshop 3: CE marking 16.45 u Discussion session

Programme day three

Medical device vigilance

  • Adverse event reporting
  • Reporting requirements
  • Post-market surveillance (PMS)

Workshop 4: Vigilance

Discussion session

Drug/device combinations

  • Drug or device?
  • Examples of classification

Discussion session

Devices incorporating material of animal origin

  • Animal-derived materials legislation
  • Directive 2003/32/EC

Discussion session

The revision to the regulations for medical devices

Question and answer session

Presenters

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.

Will Burton

Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA).

He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.

Theresa Jeary

Theresa Jeary works for SFL as Head of Combination Products. She was previously Head of the Notified Body for Medical Devices at LRQA, where she was responsible for Devices Drug products and Class III Medical Conformity Assessment for a wide range of medical devices, including In-Vitro Fertilization Media and Solutions for Organ Preservation. 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.

Theresa 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, she 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, she 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. She holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.

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.

Book now

11-13 Nov 2019
11-13 Nov 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
GBP 1,549.00
EUR 2,169.00
USD 2,416.00
Until 4 Oct*
Enrol now
13-15 May 2020
13-15 May 2020 Rembrandt Hotel, London
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
11-13 Nov 2020
11-13 Nov 2020 Rembrandt Hotel, London
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • 42 Technology Ltd
  • Abbvie Deutschland GmbH & Co. KG
  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Air Liquide Santé International
  • Becton Dickinson İth. İhr. Ltd. Şti.
  • Blau Pharmaceutical Services
  • Blue Reg Europe
  • Bristows LLP
  • Contipro a.s.
  • DCA Design International
  • Ego Pharmaceuticals Pty Ltd
  • J&J Medical Middle East
  • Johnson & Johnson Limited
  • Larix A/S
  • Martindale Pharma
  • Meda Pharmaceuticals Limited
  • Medart A/S
  • Medtrade Products Ltd
  • Merck Serono SA
  • Norgine
  • Novartis Pharmaceuticals UK Ltd
  • Olympus KeyMed Ltd
  • Research and Markets
  • Sabic Innovative Plastics
  • Sanofi-Aventis Deutschland GmbH
  • Systagenix Ltd
  • Systagenix Ltd (an Acelity company)
  • Teva Czech Industries S R O
  • Teva UK Ltd
  • Walker Filtration Ltd

Good content, good activities, good presentations and very experienced speakers.

Luis Mendoza Burgos, Head of Global Patient Safety, Ipsen Ltd

It was a well organised course with knowledgable speakers. The content is very broad but to the point.

Emma Van Til, Regulatory Affairs Associate , Ophtec B.V.

it was very interesting and detailed. The speakers were understandable and kind. I particularly found that Janette was inspiring.

Joan Wan, RA Pharmacist, Guerbet

Before the course I knew very little on MDR and now my visibility has hugely increased. The content was heavy but just right. The presentation and speakers were balanced and paced perfectly. I can not say anything to improve.

Jeffrey Watts, Principal Quality Engineer, BD

The course was well laid out in terms of topics and depth. Each topic was touched on in day one, but knowledge and understanding was built upon each day, which increased retention. The speakers were all very knowledgable on their subjects and easy to approach with any questions.

Isha Hodgson, Test Lab Supervisor, Becton Dickinson

Very comprehensive, complete overview, interesting topics, great speakers, good organisation as well!

Steven Vinkx, Quality Engineer, Quality by Design

Very practical and useful course which provides a general view of the MD regulation in Europe.

Emmanuelle Tourte, Head of Regulatory Compliance & Data Management, Guerbet

Good, informative, friendly, flexible.

Jo Mair, Project Manager, University of Edinburgh

Good presenter, I really understood the course.

Ramandeep Walia, Regulatory Affairs Manager, Novartis Pharmaceuticals Limited

Great course!

Tracy Leong, Quality Lead, BTG

Good selection of speakers and comprehensive

Martin Aigner, Quality Product Owner, Baxter AG

The course was excellent with extremely knowledgeable presenters who were open to discussion and had good real world examples during the presentations

Daniel Jacob, , Baxter

Content was very informative and the speakers were brilliant, knowledgable

Christina Obafemi, , Walgreens Boots Alliance Services Limited

Excellent

Mirusha Thanaseelan, Regulatory Affairs Associate , Weifa AS

High class speakers, very knowledgeable

Michelle Pugh, Quality Manager, Inivata Ltd

Appropriate level of detail

Oliver Gazeley, Sector Project Manager - Med/Sci, DCA Design International Ltd

Enjoyable, informative,

Sorcha Murphy, Regulatory Affairs Specialist, Johnson & Johnson Medical Ltd.

Very good

Lene Ultved, Customer Feedback Professional, LEO Pharma

Very good comprehensive overview. Speakers show experience and motivations. Presentations helpful.

Beata Bulawa, Regulatory Affairs Manager, Grunenthal GmbH

Very well organized, speakers very competent

Francesca Porchia, Regulatory Affairs Specialist , Abiogen Pharma S.p.A.

Good course

Ali Mohammed AlHawas, , Saudi Food and Drug Authority

It was informative

Abdullah Khalaf Siran, , Saudi Food and Drug Authority

It is a good course to start for anyone interested in medical device regulations

Thamer Abdullah AlArwan, , Saudi Food and Drug Authority