The European Commission's update reveals a growing pipeline of submissions approaching MDR designation, but little hope for a short-term increase in in vitro diagnostic capacity. Notifying Bodies do not have the resources to implement the new IVDR.
The European Commission provided an update on the progress of notified body applications under the new regulations, revealing a growing pipeline of submissions that are approaching medical device designation but little hope of a near-term surge in in vitro diagnostic capacity. For this reason in needed to review the due dates and also to propose a new strategy for the invitro diagnostic devices.
At the time of the December update, there were only six notified bodies designated under IVDR. Another was in the final stages of the process, with designation and its addition to the EU's New Approach Notified and Designated Organizations (NANDO) database as the only two remaining steps. The upshot is the problems that led the EU to switch to a staggered rollout of IVDR are unlikely to change this year, unless there is a sharp acceleration of the designation process.
The Commission proposed longer IVDR transition periods because of the "grave shortage of notified body capacity" that was made worse by the fact all the designated notified bodies were concentrated in three countries. The lack of progress means those issues may remain in place as the waves of IVDR deadlines approach.
We are still on the lookout for all the information that continues to be published soon!
Thanks and source information: MedTechDIVE