The European Medical Device Industry associations COCIR, EDMA, EHIMA, EUCOMED, EUROMCONTACT, EUROM VI and FIDE, representing 95% of the medical device industry, have come together to express their collective concerns about the proposed recast of the Medical Devices (MD) Directives.

The industry feels strongly that there is no evidence-based justification of the need for a recast of the MDDs. The recent revision of the existing medical device legislation has confirmed that this regulatory framework is adequate, and the impact of the minor changes introduced in the new European Directive 2007/47/EC still need to be assessed, so it is premature to reopen the discussions.

A consolidation of the Medical Device and the Active Implantable Directives is acceptable in principle, but due to significant differences, the IVD Directive must remain independent. The current MD Directives provisions, such as the implementation of the European database, must be reinforced.

There is no substantiated evidence that there is a need for a centralised European agency for Medical Devices to take on a role in classification, pre-market approval of “highest risk” devices, Notified Bodies and post-market activities. The concerns raised by the EU Commission can be addressed through improved implementation of existing measures.

Any proposed revision of the Medical Devices Directives should ensure the adoption of the Global Harmonization Taskforce (GHTF) regulatory model.

The Trade Associations believe that the existing framework, in the spirit of the GHTF principles, is working well and contributes to patients’ timely access to safe and innovative medical technology. Reopening regulatory discussions at this point threatens the future competitiveness of our industry which comprises both multinational companies and SME’s.

More information on the concerns expressed by the Medical Device Industry are compiled in a Joint Position Paper posted on the Associations websites.

Reference Document: Joint industry position paper on recast of the medical devices directives

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: Jesús Rueda, EDMA Regulatory Affairs Manager (Tel. +32 2 777 0272)