Recast of the Medical Devices Directives is “not needed”
The European Medical Device Industry associations resist the European Commission's proposal to build up a centralized European agency for Medical Devices. The new authority is planned to regulate MD affairs, e.g. classification and pre-market approval of “highest risk” devices. According to the MD Industry, the concerns of the EU Commission can be addressed through improved implementation of existing measures.
They are not always friends, but this time they stick together: COCIR, EDMA, EHIMA, EUCOMED, EUROMCONTACT, EUROM VI and FIDE represents 95 percent of the medical device industry and they came together to express their concerns about the proposed recast of the Medical Devices (MD) Directives.
The European Commission plans to create a new European Agency for Medical Devices to regulate classification, premarket approval of „highest risk“ devices Notified Bodies and post-market activities.
But the existing industry assoziations believe, that the concerns raised by the EU Commission can be addressed through improved implementation of existing measures. In a common press release the assoziations write that there were be no evidence-based justification of the need for a recast of the MDDs and additionally that recent revision of the existing medical device legislation had confirmed that this regulatory framework is adequate. Furthermore they argue "that the impact of the minor changes introduced in the new European Directive 2007/47/EC still need to be assessed", so it were premature to reopen the discussions.
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.
03.07.2008
