Medical technology

Directive 93/42/EEC applies to the use of materials in medical applications within the European Community. In August 1994 this directive was transposed into German law by passage of the Medizinproduktegesetz (Medical Devices Act). The pertinent national and international standards, such as ISO 10993 and DIN EN 30993-1, cover the details of the approval process. The current German Pharmacopoeia (DAB) and the European Pharmacopoeia can be used as supplementary regulatory works to make decisions in special cases. In case of doubt workpieces must be tested by the manufacturer or user under the conditions of use.

We would be happy to answer any further questions. Please get in touch with our regional contacts or our customer service center.