Expert Panel View On First Ebola Test Submission: Reservations About Use In EU
The IVD expert panel has reviewed the performance of the 16th IVD that it has been asked to assess. The outcome is generally favorable – but with some reservations, including its use in the EU.
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The newly established expert panels have published seven opinions so far under the Medical Device Regulation. The first six were for novel devices or uses. Now an established device has been reviewed, and the expert panel agrees longer-term data are needed.
The latest notified body listing brings total number of EU designated Medical Device Regulation testing and certification organizations to 35.
Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.