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The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU.

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 firm will use funds from the round, led by the Midlands Engine Investment Fund, to develop its optical point-of-care diagnostic testing platform.

While companies are expected to have their IVDs certified under the new regulation by 2022, manufacturers are frustrated by the slow pace of the certification process.

MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.

While stakeholders hope that the country will continue to accept the CE-IVD mark after Brexit, the issue is unresolved, leaving firms in the dark as to what the future may bring.