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

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

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

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

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%
Enrol now

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Previous customers include...

  • Abbott Diabetes Care Ltd
  • Abbott Products GmbH
  • Acrostak
  • AKOS Limited
  • Alliance Pharmaceuticals Ltd
  • Baxter World Trade SPRL/BVBA
  • Bayer Pharma AG
  • Becton Dickinson East Africa Limited
  • Cook Italia
  • Covidien (UK) Commerical Limited
  • Diamond BioPharm Ltd
  • GAMA Healthcare
  • Inivata Ltd
  • J&J Medical Middle East
  • Kyphon Sarl
  • Larix A/S
  • Medtrade Products Ltd
  • MHRA/NIBSC
  • Mölnlycke Health Care AB
  • Neurodan A/S
  • Pierre Fabre Dermo-Cosmetique
  • RIVM
  • Shire Pharmaceuticals Ireland Ltd
  • Systagenix Wound Management
  • Takeda GmbH
  • Teva Czech Industries S R O
  • Teva UK Ltd.
  • Tyco Healthcare
  • United Therapeutics Europe Ltd
  • Wyeth Europa Ltd

Good, informative, friendly, flexible.

Jo Mair, Project Manager, University of Edinburgh

Good selection of speakers and comprehensive

Martin Aigner, Quality Product Owner, Baxter AG

Good presenter, I really understood the course.

Ramandeep Walia, Regulatory Affairs Manager, Novartis Pharmaceuticals Limited

Great course!

Tracy Leong, Quality Lead, BTG

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.

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

Beata Bulawa, Regulatory Affairs Manager, Grunenthal GmbH

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.

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