Following a warning from health ministers, the EU executive agreed on a list of actions to ease the transition into the new framework for medical devices as its sluggish implementation threatens a shortage in Europe.

The list was approved by the Medical Device Coordination Group (MDCG) chaired by the European Commission on Monday (29 August) and is meant to address the issues raised at the Employment, Social Policy, Health and Consumer Affairs EU Council in June.

Considering the lack of notified bodies to assess the conformity of these devices, the Commission has already proposed a progressive roll-out of the main provisions of the IVDR regulation to avoid significant disruption in the supply of various essential devices on the EU market.

Notified body capacity and availability of medical  devices and IVDs
August 2022