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.

15-17 May 2019

& 11-13 Nov 2019

GBP 1,849
EUR 2,589
USD 2,884

Book now

Course Overview

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

Why you should attend

  • Understand the new Medical Device Regulation (MDR) n Learn the role of a Notified Body
  • Know what a Competent Authority expects
  • Hear more on classification
  • Better understand Conformity Assessment Procedures n Comply with manufacturing responsibilities
  • Discover medical device vigilance
  • Plan your clinical evaluations
  • Discuss Drug/Device combinations

Who should attend

Past delegates include personnel from the following departments:

  • Regulatory Affairs
  • Pharmacovigilance
  • Quality Assurance
  • Technical Support

This seminar will be of 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

Europe and the Medical Device Directives

  • What is a Competent Authority, Notified Body and an Authorised Representative?
  • How do they inter-relate?
  • Responsibilities of each party

Classification of Devices

  • Review of definitions
  • The 18 rules

Conformity Assessment Procedures

  • Optional routes for each class
  • What is required for each class

Workshop 1: Classification

Programme Day Two

Manufacturer’s Responsibilities

  • Technical file and design dossier requirements

Quality Systems

  • EN ISO 13485
  • The requirements for a quality system

Clinical Evaluations

  • European Regulatory environment
  • When are Clinical Investigations necessary?
  • What is required by the Competent Authorities, Ethics Committee and Notified Body?

Workshop 2: Clinical Evaluations

Medical Device Vigilance

  • Adverse Event reporting
  • Reporting requirements
  • Post Market Surveillance (PMS)

Workshop 3: Vigilance

Programme Day Three

Labelling of Devices

  • Use of language and symbols
  • Instructions for use

Workshop 4: Labelling

Drug/Device Combinations

  • Drug or device?
  • Examples of classification

Devices Incorporating Material of Animal Origin

  • Animal derived material legislation
  • Directive 2003/32/EC

The Draft Proposed Revision to the Regulations for Medical Devices and In-Vitro Diagnostics

Presenters

Janette Benaddi (15-17 May 2019, 11-13 Nov 2019)

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 (15-17 May 2019)

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 (15-17 May 2019)

Theresa Jeary is Head of the Notified Body for Medical Devices at LRQA, where she is 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. She 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.

Book now

15-17 May 2019
15-17 May 2019 DoubleTree by Hilton London-West End, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now
11-13 Nov 2019
11-13 Nov 2019 Venue not yet confirmed GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Bayer Healthcare
  • BD International
  • Celyad
  • Cochlear Europe Ltd
  • Contipro a.s.
  • ConvaTec UK Ltd
  • Coopervision Manufacturing Ltd
  • Depuy CMW
  • Det Norske Veritas
  • ELPEN PHARMACEUTICAL CO.INC.
  • Ewopharma AG
  • FibroTx OU
  • GC Europe NV
  • Mallinckrodt Medical BV
  • Medtronic International Trading Sarl
  • Medtronic Limited
  • Mundipharma Research Ltd
  • Perrigo
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Sabic Innovative Plastics
  • Shire Pharmaceutical Ltd
  • Symogen Limited
  • Systagenix Wound Management
  • Takeda GmbH
  • Takeda Pharma A/S
  • Tyco Healthcare
  • University of Edinburgh
  • Vifor SA
  • Winthrop Pharmaceuticals UK Ltd

Good, informative, friendly, flexible.

Jo Mair, Project Manager, University of Edinburgh

Great course!

Tracy Leong, Quality Lead, BTG

Good presenter, I really understood the course.

Ramandeep Walia, Regulatory Affairs Manager, Novartis Pharmaceuticals Limited

Good selection of speakers and comprehensive

Martin Aigner, Quality Product Owner, Baxter AG

Content was very informative and the speakers were brilliant, knowledgable

Christina Obafemi, , Walgreens Boots Alliance Services Limited

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

Excellent

Mirusha Thanaseelan, Regulatory Affairs Associate , Weifa AS

Very good

Lene Ultved, Customer Feedback Professional, LEO Pharma

Very well organized, speakers very competent

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

Enjoyable, informative,

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

Appropriate level of detail

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

High class speakers, very knowledgeable

Michelle Pugh, Quality Manager, Inivata Ltd

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

Beata Bulawa, Regulatory Affairs Manager, Grunenthal GmbH

It was informative

Abdullah Khalaf Siran, , Saudi Food and Drug Authority

Good course

Ali Mohammed AlHawas, , 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