Eucomed, the European medical technology industry association has expressed its welcome to the adoption of the proposals for new regulations for medical devices and in-vitro diagnostics medical devices by the European Commission.
The revised regulatory framework for medical devices is comprised of 2 proposals:
- A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices);
- A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).
However, Eucomed also expressed its concern towards the wider usage of “Scrutiny Mechanism”, already in practice today by Directive 2003/32/EC, recently repealed by Regulation 722/2012, on medical devices utilizing tissues of animal origin to other high risk devices.
The European industry believes that “Scrutiny Mechanism” will fundamentally change the current European system and will bring it much closer to the centralized pre-market authorization system found today in the United States by the US FDA (Food & Drug Administration). Such a system, while empowering EU authorities to have a “asecond look” at individual assessments of medical devices and make their views heard before a device is CE Marked and placed on the European market will create a situation in which Authorities may be held accountable for devices they have authorized.
The concerns above were addressed during the press conference of September 26th 2012, by the EU Commissioner for Health and Consumer Policy, John Dalli, clearly stating the new proposals are not aimed to create a pre-market authorization system in Europe but do aim to prevent incidents of fraud as induced by the PIP incident.
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