European Commission On Track To Appoint Expert Panel Members By End Of July
Until the EU’s MDR expert panels are in place, notified bodies cannot complete conformity assessment of certain high-risk devices. But progress is being made at last.
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The speed to market for innovative products in the EU has been hampered because of the time it has taken to set up “expert panels” under the Medical Device Regulation. Will these products now make 26 May 2021 deadline?
Manufacturers of COVID-19 tests may now have longer to comply with the IVD Regulation. But those from third countries need to be aware of the deadlines and hurdles ahead and act now.
The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.