The MPEUAnpG aligns national medical device law with EU requirements. This has given the BfArM and the Paul Ehrlich Institute more powers, such as prohibition rights and recalls in the event of proven risks (see also the MPDG). Nevertheless, the basic responsibility for necessary measures remains with the country authorities.
The regulation also becomes more concrete in the fight against counterfeit or insufficiently certified products. This is where the Council of Europe's "Medicrime" Convention comes into play.
In this well-regulated market, it is essential to have knowledge of the facts and an eye for detail. On request, NEMIUS offers its professional expertise to help you master the numerous challenges.
