IVDs in the future will require certification in England, Scotland, and Wales, while companies will still be able to sell tests in Northern Ireland under existing EU regulations.
IVD manufacturers are hoping questions related to the UK's pending exit from the EU, as well as the new European IVD Regulation, will soon be resolved.
The companies are developing a blood-based assay for differentiating lung cancer from benign disease in patients testing positive in low-dose CT screens.
If the UK leaves the EU on Oct. 31 without a deal, the Medicines and Healthcare Products Regulatory Agency will start regulating medical devices and IVDs.
The change will be felt most immediately in Europe, where the Dutch molecular diagnostics company recently secured a CE-IVD mark for its MammaPrint BluePrint kit.
