Masterstudiengang "Drug Regulatory Affairs"


System regulating Medical Devices for Use in Animals

Dagmar Hintz (Abschlußjahr: 2010)

Language: English

Within the European Union, products being the veterinary counterpart of medical devices are not regulated by special legislation. The term “Medical Device” is defined for human use only, so legal requirements for these are formally not applicable and standards not binding for their veterinary counterparts. For a legal definition of these products is currently missing, the term “Medical devices for veterinary use”, abbreviated as MDVUs, shall be introduced for the purposes within the thesis in hands.

Some of the MDVUs are formally equated to veterinary medicinal products, but the extend and classes of products equated to veterinary medicinal products can differ from European to national level. Moreover, in practice the main problem is that the practical consequences of this equation are not clear in most cases. Interpretations and Guidelines available are written and published for veterinary products and can not simply be transferred to MDVUs. For other types of MDVUs only general regulations apply such as the provisions for general product safety laid down by directive 2001/95/EC and/or chemical preparations, which shall ensure the safety of the consumer or the person applying the device respectively, and e.g. provide minimum requirements for labelling.

Within this thesis, the current situation on European and national level taking Germany as an example is elucidated. Therefore the basic motives are discussed first at European and German level. Afterwards it shall be evaluated by means of a decision analysis as a rationale tool, if a revision of regulating MDVUs is necessary and on which level this would make sense. Therefore, in the first run the parties involved and their interests are described, criteria for evaluation collected and different alternatives are described and discussed by mentioning their advantages and disadvantages. Finally, a conclusion and outlook on this question is provided.

Pages: 41, Annexes: 0