EDMA vítá revizi direktivy o vigilanci

EDMA welcomes reviewed Guidelines on Vigilance

The European Diagnostic Manufacturers Association, EDMA is delighted with the inclusion of In Vitro Diagnostics issues in the revised Guidelines on a Medical Devices Vigilance System by the European Commission.

The revised MEDical DEVices Guidelines (MEDDEV) on a Vigilance System has just been published on the European Commission’s DG Enterprise website as MEDDEV 2.12-1 revision 5 dated April 2007. They are the result of more than two years of hard work carried out notably in a working group, part of the Medical Devices Expert (MDEG) Vigilance Group. EDMA has been an active partner in the review process, attending all the MDEG Vigilance Working Group meetings.
Together with the integration of the In Vitro Diagnostic (IVD) Medical Devices’ issues into the document, EDMA is pleased to see that the opportunity was taken to review practises in the light of experiences, as well as the inclusion of pertinent Global Harmonisation Task Force consensus documents into the MEDDEV.
The MEDDEV promotes a common approach by not only manufacturers and notified bodies but also National Competent Authorities.

European IVD manufacturers look forward to the full adoption of the guidelines by National Authorities and to the harmonisation of national practices.

Background:
EDMA, the European Diagnostic Manufacturers Association represents National Associations and major companies engaged in the research, development, manufacture or distribution of In Vitro Diagnostic (IVD) medical devices in Europe. Through its affiliated National Associations, EDMA represents in total more than 500 companies (or over 700 legal entities) across Europe. The mission of EDMA is to raise awareness of the importance, usefulness and added-value that diagnostic information can provide to healthcare. For this purpose, EDMA cooperates with European institutions, patients groups, trade associations, health professionals and academia to support an appropriate regulatory system, to work towards a realistic economic environment for healthcare in Europe and to be an effective voice in globalisation.
For more information, please visit EDMA website or contact:
Karen Howes, EDMA Regulatory Affairs Director (Tel. +32 2 777 02 74)