Commission Told New EU Regulation ‘Clearly Untenable’ And ‘Not Ready To Function’

17 Apr 2019

With just over 13 months until the EU Medical Devices Regulation is fully applicable, EU medtech manufacturers are imploring the European Commission to speed readiness of the new regulatory system or patients and industry will suffer.

Business time concept as a group of running businessmen and businesswomen using a giant clock to cross over a cliff as a bridge as a metaphor for schedule and appointment speed as a 3D illustration.

The regulatory situation in the EU in terms of the progress of the implementation of the Medical Device Regulation (MDR) is “clearly untenable” and “time has run out to build a functioning regulatory system.”

For these reasons, it is critical that the European Commission considers this “daunting situation,” according to an open letter from...