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An Introduction to the Medical Device Regulation

Management Forum
Course summary
3 days
1,849 GBP excl. VAT
English
Open / Scheduled
Next available date: 13/05/2020 - London
Course Dates
London
13/05/2020   (English)
1,849 GBP
11/11/2020   (English)
1,849 GBP

An Introduction to the Medical Device Regulation

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.

For a more advanced follow-on course from this, please see our Advanced Regulatory Affairs for Medical Devices which you may also be interested in.

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

Provider: Management Forum

Management Forum

Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors

Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...


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Contact information for Management Forum

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Reviews by course attendees

Luis
(5)
Good content, good activities, good presentations and very experienced speakers.
Joan
(5)
it was very interesting and detailed. The speakers were understandable and kind. I particularly found that Janette was inspiring.
Isha
(5)
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.
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Reviews
Course rating
(4.9)
Based on 7 reviews
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