Medical devices must carry a CE mark before manufacturers can introduce them into the European internal market. The CE mark also constitutes a declaration by the manufacturer that the device is in conformity with all the requirements of the Medical Devices Regulation and/or the German Medical Devices Act (Medizinproduktgesetz) (i.e. Declaration of Conformity).
The road to the CE mark varies in length depending on the device and manufacturer(s) concerned. However, applying for a CE mark always requires comprehensive documentation.