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).
The medical device directive 93/42/EEC was modified in 2007 by the amending directive 2007/47/EC. As a result the requirements related to clinical data have been increased consequently. There is a trend towards a plus for clinical studies/clinical trials. Also the legal requirements for clinical studies/clinical trials become stricter.
It is supposed that an adaption of the German Medicines Act (AMG) has given rise to the amendment. A complete section of the act (MPG – Abschnitt 4: §§19 bis 24)
addresses now the items of clinical trial, clinical evaluation and clinical performance (for IVD).
The requirements of clinical evaluation have increased and are specified in § 19 – MPG: