Mandatory Conformity Marking
International companies serving the German market are required to meet German and European health and safety legislation requirements. Specific German regulations (MPG) must be complied with in addition to European medical device directives (MDD) and medical device regulation (MDR). Medical device manufacturers are required to declare conformity to European Union legislation (Conformité Européenne –“CE”) for all devices with an intended medical purpose. The CE mark can be applied to the device once conformity has been declared: Medical devices, unlike pharmaceuticals, are not certified by governmental institutions but by notified bodies working on their behalf. There are some 60 such notified bodies throughout Europe, of which 10 are headquartered in Germany.
After having been approved for the European market, international manufacturers are then faced with national healthcare and cost reimbursement systems. In Germany, manufacturers are confronted with a system that is characterized primarily by statutory health insurance and, to a lesser degree, private health insurance. Both statutory and private health insurance are financed through insurance premiums (paid) jointly by the insured person, their employer, the national pension fund etc). While most EU countries have a DRG system in place for the inpatient sector, there are a number of different institutions, financing and reimbursement systems in place across the 27 member countries in the union.
The innovation-friendliness of the national health systems largely influences their uptake levels of new technologies and commercialization of new products. Germany's inpatient system is especially innovation-friendly in terms of product safety requirements and the availability of immediate reimbursement. The German DRG system allows for any CE-certified medical device to be reimbursed under existing procedures and their DRG codes (unless prohibited in the individual case). While German authorities are merely executing a prohibition right in the inpatient sector, reimbursement of a novel technology in the outpatient sector is subject to approval in each product's case.