Changes to European rules for the manufacture and marketing of medical devices within the EU, in the form of the MDR and IVDR , have resulted in amendments to Germany’s national medical devices law.
The Medical Devices EU Adjustment Act (PDF) adapts Germany’s national Medical Devices Act so as to conform to the modified EU guidelines.
The centerpiece of the statute is the Medical Devices Implementing Act, which replaces the “old” Medical Devices Act. One change from the previous rules of the Medical Devices Act is that the two supervisory authorities responsible for product surveillance at the federal level, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), will have expanded powers. In the future, they will be authorized to take protective measures which they deem necessary to prevent unjustifiable risks to patient and/or user safety arising from medical devices based on risk assessments which are to be conducted on their own responsibility. These measures include prohibiting (further) distribution and marketing of products in the national market, as well as recalls. Previously, only the national supervisory authorities had this authority.
In addition, the Council of Europe’s “Medicrime” Convention is (finally) to be implemented with respect to medical devices. The goal of the Convention is to combat the counterfeiting of medicinal products and medical devices as effectively as possible by strengthening cooperation among economic operators in the industry. The Convention will first have to be implemented into national law.back