Medical Devices and In Vitro Medical Devices Regulations: Transitional provisions [EU Legislation in Progress]

Written by Laurence Amand-Eeckhout (2nd edition, updated on 17.07.2024).

In January 2024, the European Commission put forward a proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746, to give manufacturers more time to apply the EU legislation on, respectively, medical devices and in vitro diagnostic medical devices (IVDs), without compromising safety requirements. On 25 April 2024, to avoid shortages, the European Parliament adopted its position at first reading under the urgent procedure, by an overwhelming majority. The Council adopted its position on 30 May 2024. The final act was signed on 13 June 2024 and published in the Official Journal of the EU on 9 July 2024, day of its entry into force.

IVDs are non-invasive tests used on biological samples (such as blood, urine or tissues) to determine the status of a person’s health. A considerable number of IVDs currently on the market do not yet comply with the new rules adopted in 2017, nor have they been replaced by new devices. The situation is especially critical for high-risk IVDs, used, for example, to test for infections in blood and organ donations. The regulation aims to address risks of IVD shortages in the EU and speed up the launch of some elements of the European database on medical devices (Eudamed).

Complete version

• July 2024: ‘Medical Devices and In Vitro Medical Devices Regulations: Transitional provisions‘ (2nd edition)