Medical device regulations may be simplified this year if the director of the medical devices division of the Ministry of Health, Wilfried Reischl, gets his way.
The aim of the new amendment of the Medical Devices Operating Ordinance is to reduce bureaucratic red tape and deregulation of the sector, Reischl said. Software will be included in the medical devices definition and a quality management system will also be introduced for all Class I medical devices.
To tackle the project, a working group was established with federal and regional state representation. The expert draft should be ready by this summer and is expected to be approved by the end of the year.
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