This can be a challenge for well established devices – where the history goes back so long there may not be ready access to recent primary clinical data. The regulations allow for a number of approaches including predicate comparisons, literature supported submissions and review of in house postmarket data. But there’s a default position of direct clinical data for Class III and Active Implants and Class 4 IVDs.
So how much clinical data is enough for established devices? It’s not at all clear how the new regulations will be implemented and interpreted.
So it’s timely to hear from TUV Sud’s Bassil Akra, posting on LinkedIn that new European guidance is in the works to provide some clarity. Notified Bodies are actively seeking input and anonymous case studies to build a case for practical solutions.
It’s time to speak to your Notified Body and have your say as to what is practical and reasonable. Let us know if we can help you make your case.
Supplying in Europe? We are experienced in all aspects of CE certification and European compliance. Whether entering Europe for the first time, seeking transition to the new MDR/IVDR or needing to find a new Notified Body, we can help. Contact us today for a no obigation chat: email firstname.lastname@example.org or call +61 2 9906 2984