3-Day Course: An Introduction to the Medical Device Regulation (London, United Kingdom - May 15-17, 2019) - ResearchAndMarkets.com

September 19, 2018

DUBLIN--(BUSINESS WIRE)--Sep 19, 2018--The “An Introduction to the Medical Device Regulation” conference has been added to ResearchAndMarkets.com’s offering.

This course will help you gain a comprehensive understanding of the regulatory requirements.

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.


Day One

09.30 Welcome and introduction

09.45 What is a medical device?


10.45 Discussion

11.00 Refreshments

11.15 Europe and the Medical Device

Regulation - overview of the regulations applicable for bringing a medical device to market

12.15 Discussion

12.30 Lunch

13.30 What is a Competent Authority,

Notified Body and an Authorised Representative?How do they inter-relate?Responsibilities of each party

14.30 Classification of devices

What are the classes and how do we classify devices

15.15 Discussion

15.30 Refreshments

15.45 Conformity Assessment Procedures

The routes to CE markingWhat is required for each class of device

16.30 Workshop 1: Classification

16.45 Discussion

17.15 End of day one

Day Two

09.00 Manufacturer’s responsibilities

Technical file and design dossier requirements

10.00 Quality systems

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

10.45 Discussion

11.00 Refreshments

11.15 Labelling of devices

Use of language and symbolsInstructions for use

12.15 Discussion

12.30 Lunch

13.30 Workshop 2: Labelling

14.15 Discussion

14.30 Clinical evaluations

European regulatory environmentWhen are clinical investigations necessaryWhat is required by the Competent Authority, Ethics Committee and Notified Body

15.30 Discussion

15.45 Refreshments

16.00 Workshop 3: Clinical evaluations

16.45 Discussion

17.00 End of day two

Day Three

09.00 Medical device vigilance

Adverse event reportingReporting requirementsPost Market Surveillance (PMS)

10.00 Workshop 4: Vigilance

10.45 Discussion

11.00 Refreshments

11.15 Drug/Device combinations

Drug or device?Examples of classification

12.15 Discussion

12.30 Lunch

13.30 Devices incorporating material of animal origin

Animal derived materials legislationDirective 2003/32/EC

14.30 Discussion

14.45 Refreshments

15.00 The revision to the regulations for medical devices

15.45 Question and answer session

16.00 End of seminar

For more information about this conference visit https://www.researchandmarkets.com/research/tph72l/3day_course_an?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180919005324/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Manager


For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Medical Devices



SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 09/19/2018 06:47 AM/DISC: 09/19/2018 06:47 AM


Update hourly