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.

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