An Introduction to the Medical Device Directives

LRQA presented 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 provided a detailed introduction to the European medical device legislation, explained the Directives and which products are covered, covered the involvement of Notified Bodies and how to choose one and also outlined what a manufacturer must do. Additionally, it also covered the documentation necessary to apply for the CE Mark. 

The event was suitable for anyone new to the medical device industry, those intending to place a medical device on the market, or organisation that required an overview of the medical device sector. 

LRQA’s Technical Manager for Medical Devices, Theresa Jeary, presented 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