Briefing - Medical Devices and In Vitro Medical Devices Regulations: Transitional provisions - 03-04-2024
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On 23 January 2024, the European Commission put forward a proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746, to give manufacturers time to apply the EU legislation on, respectively, medical devices and in vitro diagnostic medicalBriefing - Medical Devices and In Vitro Medical Devices Regulations: Transitional provisions - 03-04-2024
On 23 January 2024, the European Commission put forward a proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746, to give manufacturers time to apply the EU legislation on, respectively, medical devices and in vitro diagnostic medical devices (IVDs) under certain conditions, without compromising safety requirements. 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considerable number of IVDs currently on the market do not yet comply with the new rules adopted in 2017, nor have they been replaced by new devices.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 proposed 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). The proposal is now with the co-legislators. In the Council, Coreper agreed on the text of the proposal without amendments on 14 February 2024. In the European Parliament, the file was assigned to the Committee on the Environment, Public Health and Food Safety. It is expected to be voted during the April II plenary, under the urgent procedure – Rule 163 of the Rules of Procedure. First edition. The 'EU Legislation in Progress' briefings are updated at key stages throughout the legislative procedure. Source : © European Union, 2024 - EP Read more