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 EU Batteries Regulation is yet another legal instrument medical device manufacturers must address over the coming years alongside the core Medical Device and IVD Regulations.
IVD manufacturers look set to be granted up to 18 more months to comply with the EU IVD Regulation very soon.