Legal simplification for medical devices in Germany and the EU
Berlin/Wiesbaden, Germany. Despite the discussion on the German
healthcare reform, important legal objectives within the medical devices
sector will be pushed forward in the coming weeks. Thus, the 3rd amendment
to the Medical Devices Act is scheduled to be dealt with by the cabinet and
approved by parliament by the end of the year. This was the message of
Wilfried Reischl, Director of the medical devices division at the Federal
Ministry of Health in front of some 90 delegates at the BVMed symposium,
entitled: “Medical devices law” in Wiesbaden.
Furthermore, Mr. Reischl announced a fundamental revision of the Medical
Devices Operating Ordinance. The aim was, among other things, a reduction in
bureaucracy and deregulation of the sector, he said. To tackle this project,
a working group was established with federal and regional state
representation. The expert draft should be ready by summer 2006, and
approved by the end of the year.
The ministry’s medical devices expert
also highlighted three European activities each of them having considerable
consequences for the medical devices sector: the “simplification strategy”
of EU Commissioner Verheugen, which is to cut legal red tape in all areas;
the review of the “New Approach”; and the review of the Medical Devices
Directives, which, with the exception of the IVD directive, are to be
compiled into a single ordinance.
A political agreement has hitherto not been forthcoming, with the result
that the objective will probably be achieved in the first half of 2007,
under the German presidency, said Mr. Reischl. He added that it is clear now
that software is to be included in the medical devices definition.
Furthermore, a quality management system is also to be introduced for all
Class I medical devices.