The guidance is the first of several that will cover the new medical device and in vitro diagnostic regulations, which are set to come into force by 2020 and 2022, respectively.
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 group of regulatory authorities from around the world has proposed a new guidance for harmonizing the procedures for assessing medical devices, including IVDs.
