Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)

On 7 February 2022 the European Commission announced an update of the joint implementation plan for IVDR.

A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market. The MDR was envisaged to apply from 26 May 2020. In contrast, the IVDR has a date of application of 26 May 2022. In March 2020, the Medical Device Coordination Group (MDCG), composed of experts appointed by Member States, endorsed a joint implementation plan on the implementation of the MDR. The plan listed priority actions for the Member States and Commission services, to be monitored at the level of the MDCG. The MDR joint implementation plan recognized the need to carry out a similar exercise for the IVDR. The present document therefore proposes a draft joint implementation plan for the IVDR.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /