Newsalert Pharma, Healthcare and Life sciences Business Unit | The postponed application of the European Regulation on medical devices and the extension of derogations from conformity assessment procedures.

European Regulation 2020/561 (published on 24 April 2020) has postponed by one year the application of the new regulatory framework on medical devices introduced by EU Regulation 2017/745.

The European regulatory framework in the medical devices sector has undergone a recent reform with the adoption of (i) Regulation 2017/745 on medical devices (MD) and (ii) Regulation 2017/746 on in vitro diagnostic medical devices.