Three Day Course: Introduction to the European Medical Device Regulation - London, United Kingdom - November 11-13, 2019

DUBLIN, Oct. 15, 2019 /PRNewswire/ -- The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.

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.

Agenda:

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

For more information about this conference visit https://www.researchandmarkets.com/r/z4kq0q

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SOURCE Research and Markets