European Commission

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.

Of the 1,194 Horizon 2020 proposals received between 2014 and 2017, most were related to the development of IVDs, while a third were focused on personalized medicine.

The Israeli firm recently announced the results of a multicenter study of its Bladder EpiCheck test in addition to netting €2.5 million in EU funding to develop a lung cancer assay.

The test uses changes in DNA methylation patterns for the early detection of lung cancer and is based on the same platform as the firm's bladder cancer test.

The firm aims to have its test on the European clinical market by early next year, followed by a launch in the US.

MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.

The group of regulatory authorities from around the world has proposed a new guidance for harmonizing the procedures for assessing medical devices, including IVDs.

The Codex4SMEs project, which has a €3.1 million budget, involves seven countries to increase cooperation in Europe's northwest region to develop companion diagnostics.

Backed by €19 million in EU funding, the initiative, called BigData@Heart, will create a research platform that could change the way cardiovascular diseases are diagnosed and treated.

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.

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