Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Consequences of the switch of the intended use of medical devices from human to veterinary use in Germany/Europe ***
Dr. Birgit Thome-Kromer (Abschlußjahr: 2015)
Summary
Language: German
For human applications, medical devices, including in vitro diagnostics, are regulated by the European directives 90/432/EEC, 93/42/EEC and 98/79/EC.
Medical devices which are not intended for human use are not regulated by European provisions. Due to the history of the German Medicinal Products Act the classifications and therefore the regulations are different in Germany. Various provisions cover “medical devices for veterinary use” which is not transparent for manufacturers and difficult to surveil for authorities.
In the case where the application of active medical devices i.e. electronic devices changes for use in animals, the devices become regulated only by European provisions: Electromagnetic Compatibility Directive (2014/30/EU), the Low Voltage Directive (2014/35/EU) and/or the machinery directive (2006/42/EC). No additional German requirements for medical use have to be fulfilled.
When the intended use of non-sterile medical devices according to directive 93/42/EEC is changed for application in animals, they are no longer regulated by medical or medicinal provisions and are classified as consumer products.
On the other hand, medical implantable devices, sterile instruments, sutures or dressings made for humans are classified as medicinal products according to Section 2 sub-section 2 numbers 1a - 3 Medicinal Products Act (AMG) when used for animals. Although many regulations of the Medicinal Products Act are not applicable for these products, the relevant provisions are much stricter for the products for veterinary use than for those for human use. In addition, the required qualification of personnel is not suitable for guarantying the quality of the products. Standards like Good Manufacturing Practice are to be fulfilled for the production of all veterinary medicinal products regulated according to the Medicinal Products Act. Pharmacovigilance, labelling (SmPC) and marketing approval are not requested for veterinary medical devices.
The requirements for selling veterinary in vitro diagnostics in Germany are depended up on the disease type they intend to diagnose. They might either fall under the provisions of the Medicinal Products Act (Section 2 sub-section 2 number 4, AMG) or the Animal Health Law (Section 12, TierGesG) including requirements for marketing approval or they are not regulated at all.
This diversity of regulations and the wide range of provisions form non-regulated to drug like approval and production requirements is unique in Europe. It does not seem appropriate not to control medical devices for animals at all or to have higher standards for animals than for humans. Overregulation leads to off label use of medical devices made for humans which might not be perfectly suitable for animals.
Due to the lack of provisions, German authorities do not issue certifications or documents of manufacturing quality for non-regulated products. In contrast to this, the Ministry of Food, Agriculture and Fisheries of Denmark issues export certificates for CE marked medical devices also used for veterinary purposes. Although veterinary medical devices do not exist in Europe the Denmark procedure is an easy to apply method to expand the control of “CE-marked” medical devices to those for veterinary use. This allows Danish manufacturers to export their products worldwide. Per example, in the US and Thailand veterinary medical devices are included in the medical device regulations and therefore require the same import documents, which are required for human medical devices.
In summary I recommend to either include veterinary medical devices in the European provisions made for human medical devices, use the Danish model or to control the products in a risk based way comparable to the control of IVDs for the detections of epizootic diseases by the Animal Health Law. The German Animal Health Law includes requirements suitable for medical device manufacturers and leads to control of the quality and safety of the products that is appreciated by customers worldwide and guarantees animal welfare.
Pages: 44