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.
There is a much-acknowledged urgency to ensure medtech products are certified as fast as possible, with fears persisting that delays will result in notified body bottlenecks and product shortages.
After some 10 years of the implementation of the EU’s Medical Device and IVD Regulations being an annual agenda item at December Council of the EU meetings, the scale of problems remains the same.