UK government

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MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.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