The existing regulatory framework has been in place for nearly 30 years. It has been amended on an ad hoc basis in that time, but pressure to modernize it in order to better address risk management and guarantee the continued safety of medical devices sold in the European Union has been growing.
As a result, the European Commission presented two legislative proposals in September 2012, which were followed by five years of consultation and negotiation that concluded with a new set of regulations affecting manufacturers, distributors, notified bodies, importers, suppliers, and member states.