An Introduction to the Medical Device Directives


LRQA will be speaking at An Introduction to the Medical Device Directives seminar taking place on 13-15 March 2015 in London

Organised by the Management Forum the event is aimed at those wishing to gain a comprehensive understanding of regulatory requirements. 

The seminar will provide a detailed introduction to the European medical device legislation, 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. 

The event is suitable for anyone new to the medical device industry, intends to place a medical device on the market, or requires an overview of the medical device sector. 

LRQA’s Technical Manager for Medical Devices, Theresa Jeary, will be presenting on the following topics at the event: 

15 May 2015 

11.15 – Drug/Device Combinations

  • Drug or device?
  • Examples of classification 

13.30 – Devices Incorporating Material of Animal Origin 

  • Animal derived materials Legislation
  • Directive 2003/32/EC 

15.00 – The Draft Proposed Revision to the Regulation for Medical Devices and In-Vitro Diagnostics 

Don’t miss this great opportunity to hear from industry experts as they share their experience and advice, as well as an opportunity to network with people from the medical sector.