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BioMed Alliance statement on risk of shortages of CE Marked IVDs

Date: 16 January 2024

The medical community is increasingly concerned about approaching widespread issues with the availability of In Vitro Diagnostic Devices (IVDs) in Europe.

After an adjusted timescale for implementation of the IVDR implementation was adopted in 2021-2022, 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 IVDs in the near future, impacting on the care of patients, primarily those with rare disorders.