2009 – 4th version of the Medical Devices Act

The Act on Medical Devices is going to be released in its 4th version. (s. MPG) and supports the implementation of the directive 2007/47/EC.

Medizinproduktegesetz

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:

Section 19 Clinical evaluation, performance evaluation

(1) Evidence of the suitability of medical devices for the specified intended purpose shall be provided through a clinical evaluation based on clinical data pursuant to Section 3, number 25, unless, in exceptional cases with good reason, other data are sufficient. The clinical evaluation shall include the evaluation of adverse effects, as well as the acceptability of the risk-benefit balance mentioned in the basic requirements contained in Directive 90/385/EEC and Directive 93/42/EEC.

(2) Evidence of the suitability of in vitro diagnostic medical devices for the specified intended

purpose should be provided through performance evaluation based on appropriate data.

The performance evaluation should be based on:

1. data from scientific literature which cover the intended use of the medical device and the techniques involved in its use as well as a written report containing a critical evaluation of these data or

2009 – 4th version of the Medical Devices Act

Section 19

Clinical evaluation, performance evaluation

(2) Evidence of the suitability of in vitro diagnostic medical devices for the specified intended

purpose should be provided through performance evaluation based on appropriate data.

The performance evaluation should be based on:

1. data from scientific literature which cover the intended use of the medical device and the techniques involved in its use as well as a written report containing a critical evaluation of these data or

2. the results of all performance evaluation studies or other appropriate tests.

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