in vitro

Description

The Task Force 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 task force composed of IVD experts was established in 2019.

Chair

This task force is chaired by Professor Elizabeth Macintyre, Professor Christa Cobbaert, Bart Lubbers and Monika Brüggemann.

Highlights

  • Questionnaire on the current use of IVD tests in diagnostic laboratories

    The European Haematology Association Task Force on IVD in collaboration with the BioMed Alliance Task Force on IVD and with expertise from Prof. Christa Cobbaert from the European Federation of Clinical Chemistry and Laboratory Medicine, created a questionnaire on the current use of different IVD tests in diagnostic laboratories.

    The objective of the questionnaire is to gain insight into the current situation for medical laboratories, in particular the degree of (un)preparedness of medical laboratories for the IVDR implementation, and to make an accurate assessment of the potential impact that the IVDR will have on diagnostic laboratories and their test menu. The questionnaire is being largely disseminated to member organisations and other relevant stakeholders. The results will be analysed and will enable us to supply our members with relevant information and to better represent them in the implementation process. The Word version of the question is available here, and the online survey here.

  • Statement calling for urgent actions to prevent a collapse of the diagnostic sector

    In May 2021, the BioMed Alliance published a new statement highlighting a looming threat for the diagnostic sector: the slow implementation of the new In Vitro Diagnostic Regulation (IVDR), a ticking bomb for the diagnostic sector. The laboratory experts of the IVD Task Force called for immediate actions to prevent its collapse.

    The application date of the new In Vitro Diagnostics Regulation is only one year away (26 May 2022) and there are widespread concerns that the implementation is not progressing quickly enough and that the diagnostic sector is not ready. The new regulation proposes stricter safeguards for tests and additional elements in the regulatory framework for IVD tests, but so far, its implementation has been slow. As a result, not all elements and guidance are in place, making it harder for the diagnostic sector to prepare. Read the statement here.

  • STOA Workshop: The need for better EU policies for health

    In April, the European Parliament Panel for the Future of Science and Technology (STOA) organised a workshop on the new IVD Regulation and the need more evidence-based EU health related policies, in cooperation with the BioMed Alliance, ESC, EFLM and EHA. The meeting brought together a mix of policy makers and experts from the field to discuss challenges around the new In Vitro Diagnostics Regulation and the need for more evidence-based EU health related policies. At this occasion, the BioMed Alliance, EFLM, EHA and ESC published a press release, and following the meeting, the STOA Panel published a report on their website. For more information, the report from the STOA Panel is available here, and the BioMed Alliance press release here.

  • 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 IVD Task Force) 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 Task Force 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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