News about regulation on medical devices and in vitro diagnostics

As reported in the February newsletter, Germany’s National Working Group (NAKI) met to review the implementation of the EU’s new Regulation on medical devices (MDR) and in vitro diagnostic medical devices (IVDR) in German law. In early April, BIO Deutschland participated in a meeting of subgroup 1 (transitional provisions). The main topic was the discussion on the transitional provisions for the continued validity of special authorisations, launching medical products containing cells and tissues on the market and the possibility of ending initiated clinical trials before the key date. In addition, participants discussed the importance of Eudamed database functionality for the applicability of specific individual provisions of the new regulations.