in vitro

Description

The 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 working group composed of IVD experts was established in 2019.

Chair

Prof. Elizabeth Macintyre is chairing the BioMed Alliance IVD Working Group.

Highlights

  • Statement calling to speed-up IVDR implementation

    In July 2020, the BioMed Alliance published a statement calling for urgent action to ensure optimal implementation of the EU In Vitro Diagnostic devices regulation (IVDR). The statement calls on the European Commission to take into account a number of actions that should be completed as soon as possible.

    The application date for the new regulation on 26 May 2022 is approaching and adaptation to the new regulatory system is time consuming and requires a concerted effort from the European Commission, Member States and stakeholders. At the moment there are many steps that still need to be taken to ensure the regulatory system will be ready to continue guaranteeing the availability of novel and high-quality diagnostic tests. Read the statement here

  • Participation MDCG Working Group on IVD

    Prof. Elizabeth Macintyre (Chair of the BioMed Alliance IVD Working Group) is representing us and provides scientific input in the European Commission Medical Devices Coordination Group (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

  • Kick-off meeting

    The kick-off meeting of the new Working Group on In Vitro Diagnostics took place on 12 November 2019 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.

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