Two new Regulations concerning medical devices and in vitro diagnostic medical devices entered into force on 25 May 2017, and will fully apply from 26 May 2020 and 2022, respectively. These new Regulations overhaul the current regulatory framework, posing issues for the medtech sector.
This Guidance Note explains why the new Regulations were needed,what they change and how businesses should prepare. Reference should also be made to the current rules that apply to medical devices (see GNL 13 Medical Devices Regulation – the Current Rules).
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