Why IVD Industry Must Address Growing EU Urgency And What Factors Are At Play
It is just over 18 months until the full application of the IVD Regulation. The MDR may be the main focus of attention, but there is no less urgency when it comes to preparing for the IVDR. But the industry is dragging its feet.
You may also be interested in...
If the tools are not in place by the end of 2020 to allow diagnostics companies to comply with the EU IVDR, the 2022 compliance deadline should be delayed, say EU notified bodies.
The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.
Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.