EU Medtech Reform Trilogues Take Off Amid Turbulence and Late Landing Fears

We have reached the critical phase of the EU negotiations on the proposed Medical Device Regulation and In Vitro Diagnostic Regulation, now the long-awaited trilogue meetings between the European Commission, the Council of the European Union and the European Parliament have begun. Five are planned, but the timings of the final two are not yet written in indelible ink, and the whole program may yet be supplemented or delayed¹.