1995 – Act on Medical Devices

In News by F.TolkmittLeave a Comment

The German Act on Medical Devices (MPG) will enter into force on 1 January 1995 and implements the European Directive 93/42/EEC on medical devices into national law. As a consequence  the Act on Medical Devices replaces the existing Medical Devices Regulation (MedGV). A Medical Device Vigilance System is established by the European Medical Product Legislation. The previously scattered regulations for medical devices across several Directives are now standardized.

The Medical Devices Act relies on the requirements of the Directive 93/42/EEC in paragraph 19 concerning clinical data.

Act on Medical Devices

The Medical Devices Act (abbr. MPG) refers in Germany and Austria to the national implementation of the European Directives 90/385/EEC on active implantable medical devices, 93/42/EEC on medical devices and 98/79/EC on in vitro diagnostics. The Medical Devices Act regulates technical and medical requirements for the placing of medical devices on the european market. Since becoming effective in 2002 the term medical device is being given by the MPG a distinct definition different from drugs or transplants. Due to european and national medical device legislation commercially viable medical devices can be recognized by CE-marking. Compliance with guidelines is controlled by notified bodies in accordance with 93/42/EEC (EC conformity assessment).

 

Leave a Comment