in vitro

The new Working Group on In Vitro diagnostics was established based on decisions in the BioMed Alliance Taskforce on Regulatory Affairs and Medical Devices.

A new EU regulation on In Vitro Diagnostics will come into effect in 2022 and will have a major impact on the evaluation and approval process of IVDs. In preparation for this, and to facilitate member society cooperation on the regulatory aspects of in vitro diagnostics, this taskforce is established in 2019.

The kick-off meeting of the new Working Group on In Vitro Diagnostics took place on 12 November and brought together experts from member societies and other key players in the field. During the meeting, we discussed the new regulation with representatives of the European Commission, Industry, Notified Bodies and Medical Societies.

Prof. Elizabeth Macintyre is chairing the BioMed Alliance IVD Working Group and will also represent us and provide scientific input in the European Commission MDCG IVD Working Group. Input from our members along with solutions for a smooth implementation of the regulation will be included in the work of the EC IVD Working Group.

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