Law Governing Medical Devices

Medical device legislation is defined at European level within the framework of directives and regulations which are to be observed in full in the near future, and at national level within the framework of the Medical Devices Act as well as various more specific ordinances.

In the manufacture and sale of medical devices, the main focus is on the differentiation between other objects, products and substances (e.g. pharmaceuticals, cosmetics) and the implementation of a conformity assessment procedure in order obtain the CE certification required for placing on the market.
 
We provide advice on these areas of medical device legislation, as well as on issues such as medical device advertising, the conduct of clinical trials for medical devices, liability for defective products, among other requirements, in accordance with the German Product Liability Act and for the reimbursement of medical devices within the framework of special care models with the statutory health insurance funds (§ 140a SGB V) and the procedure for evaluating new examination and treatment methods with medical devices of a high risk class (§ 137h SGB V).