One of the biggest challenges facing Notified Bodies at the moment is their re-designation under MDR. For some, this challenge has proven to be too great and they have decided to pull out of the race. In the last few weeks UK Notified Body LRQA has decided not to pursue MDR designation and UL has partnered with Polish NB PCBC, rather than seek designation themselves. Many UL clients have already transitioned to their Polish partner. We have also seen Swiss NB QS Zurich make the decision not to continue their re-designation journey.

For those Notified Bodies still wishing to transition, it’s not an easy road. So far, only one EU27 NB, TUV SUD has managed to obtain the holy grail. The other successful NB is BSI UK, but post Brexit, this will likely be of little consequence.

So where does this leave the thousands of medical device manufacturers who themselves need to transition to MDR in coming months? At the moment, we cannot predict what will happen with the remaining Notified Bodies, but that should not stop manufacturers being ready to transition as soon as their NB (or a new NB if theirs doesn’t make the grade) is able to provide the service.

If you haven’t already started, start NOW. Revise your QM and SOPs in line with new requirements. Update your Technical Files. Revisit your clinical evaluations. Check whether your devices will be reclassified. Take a long, hard look at your PMS and PMCF. GET SOME TRAINING….

If we can help – get in touch….