Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Market Surveillance of Medical Devices in Germany and Europe

Dr. Beate Golba (Abschlußjahr: 2004)

The aim of this thesis is to outline the legal basis of market surveillance of medical devices in Germany, considering the European medical device directives and to discuss the newly developed German market surveillance concept in comparison with the surveillance strategies in other Member States.

The German Medical Act Law (MPG) is based on the European Medical Device Directives, which belong to the New Approach System. According to the principle of the New Approach, the manufacturer bears the responsibility for the compliance of products. The manufacturer is however subject to surveillance by the national authority. Market surveillance administration and notification procedures are established in the medical device directives but besides this, the Member States are authorised to determine for themselves the degree and intensity of market surveillance operations. According to the MPG, all activities concerning medical devices are subject to supervision.

With the second amendment of the MPG enforced in 2002, the previously provided spot checks taken by the competent authorities to verify the compliance of the product have been replaced by the requirements of (more) systematic, risk-differentiated supervision. This paradigm-shift resulted in intense discussion between the Laender on selection criteria for manufacturers, the degree and technical implementation of supervision. Two market surveillance concepts have been developed which are argued in this thesis.

A Standard Operation Procedure which should ensure common inspection criteria leaves the detailed stipulations for risk-differentiated supervision to the Laender.

The comparison with market surveillance strategies of other Member States has shown that there are different concepts of systematic market supervision, whereby non-case-related supervision is mostly related to the manufacturer of class I devices and custom-made devices. The conduct of implementation varies from the review of technical documents to on-site inspections.

The outcome of the review of the Medical Device Directive regarding the market surveillance fields in the Community is described. An European Market Surveillance Group (MSOG) has been created which has been successful in the development of common technical criteria concerning particularly specific cases such as "miracle products". However a concrete concept which details the degree and the technical conduct of market surveillance is not to be expected in the near future.

Pages: 47