Today, on 5 March 2020, the German Bundestag will finally vote on the draft bill to reform German medical device law, as it is to be adapted to EU requirements. The aim is to create a single EU market for medical devices with high quality and safety standards. For the BfArM (Federal Institute for Drugs and Medical Devices) and the PEI (Paul Ehrlich Institute) this would mean that they – instead of the state authorities – would take responsibility for excluding risky medical devices from the market. The counterfeiting of drugs and medical devices would also be made considerably more difficult.
Three motions by two parties on this issue will also be put to the vote, all three of which call for preventive or interception measures on possible weaknesses in the new laws. We are curious to see how it all turns out.