EU Notified Bodies Demand IVDR System Readiness Or Deadline Review By Year End
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.
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TÜV Rheinland has been designated as a notified body under the IVD Regulation. Its appointment is a reminder of how many more notified bodies are needed if the IVDR is to be implemented effectively and on time.
The IVDR implementation schedule is problematic. European notified bodies say solutions must be grasped if public health is not to suffer.
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.