Urgent action needed to avoid widespread shortage of in-vitro diagnostic tests

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In a new statement, BioMed Alliance highlights its increasing concern about the availability of In Vitro Diagnostic (IVD) testing devices in Europe. Persisting problems with the implementation of the In Vitro Diagnostics Regulation (IVDR), insufficient certificates issued, the failure to deliver the EUDAMED database and general unpreparedness of the sector could lead to the disappearance from the market of a large number of essential IVD tests in the near future and related loss of international competitivity compared to other jurisdictions. The document calls for a mix of short-term solutions (including an extension of the transition period) and more longer-term reforms of the system to ensure pressing challenges are addressed.

EHA has been on the forefront of engagement with regulators and stakeholders on implementation of the IVDR, notably through the BioMed Alliance IVD Taskforce. BioMed Alliance, on behalf of 36 European medical and research societies and over 400.000 healthcare professionals, including laboratory professionals, has been a strong advocate for the academic laboratory diagnostics sector.

“As Biomed Alliance president and founder of its IVD taskforce, I encourage you to disseminate this statement to your national competent authorities and bodies involved in ensuring optimal diagnostic services.”

Elizabeth Macintyre, EHA Past President / chair, European Affairs Committee

Find the BioMed Alliance statement here.

For more on EHA’s advocacy on the IVDR, see here.

Last Updated on Monday 22 January 2024.