In a statement from January 2024, BioMed Alliance highlights its increasing concerns about approaching widespread issues with the availability of In Vitro Diagnostic Devices (IVDs) 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 IVDs 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.