Masterstudiengang "Drug Regulatory Affairs"


Angemessenheit der Regelungen zum Vertrieb von Medizinprodukten

Claudia Hahne (Abschlußjahr: 2006)

Language: English

This master-thesis deals with the question if German legislation for distributors ensures an adequate product safety for medical device at that part of the trade chain.

The item „distributor“ is not specified in the Act of Medical Devices. The responsibility of the distributor starts after first placing medical devices on the market by the manufacturer. As representatives for the multitude of distribution channels the pharmacy, the medical supplier “Sanitätshaus” and the whole sale trade are chosen. Medical devices, which could endanger human health, has to be distributed by pharmacy.

In reference to the Act of Medical Device the distributor is liable to ensure that there is no risk for the user coming out of the medical device before placing on the market. If the distributor delivers medical devices especially to experts he has to be able to provide technical information to them en or to instruct them in the proper handling. Within the scope of the Medical Devices Vigilance System the distributor is obliged to cooperate with the manufacturer and the authorities and to make all necessary information available.

An additional regulation relevant and binding for the pharmacy in this context is the Pharmacy Ordinace, The pharmacy and the “Sanitätshaus“ are health care provider according to the Social Security Code V. On the basis of this legislation they have to establish a quality management system. There are no further regulations for the whole sale trade with influence in product safety. But these distributors can stick to the guidances on Good Distribution Practice publishes by Eucomed.

The Federal Ministry for Health is empowered to issue ordinances for all companies dealing with medical devices. Up to now no ordinance has been implemented.

It gets obvious that the distributors have to fulfil the same obligations in reference to the Act of Medical Devices, but they are subject to different regulations. The best instrument to ensure the product quality at that part of the trade chain as well seems to be the implementation of a quality management system, because all relevant processes, which are necessary to fulfil the obligations of the Act of Medical Devices completely, can be controlled with it. This can be a adequate qualification of the staffs, the proper storage of the medical devices or a complete documentation. It is indicated to establish an obligation for the certification of these quality management systems to ensure the supervision by Notified Bodies.

The legislation pharmacies are subjected to do not lead to much more product safety, because the scope refers mainly to medical products. It is necessary to improve the adjustment between the regulations for medical devices and for pharmacies to achieve a better product safety in reference to the obligation for the distribution channel pharmacy.