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Hello,
We currently hold an ARTG Certificate for a class II medical device that lists our 510(k) as market authorization evidence. We have other ARTG certificates for the same product with other Sponsors that list the EU MDD as market authorization evidence. As we have chosen not to transition to the EU MDR, we would like to change the market authorization evidence from EU MDD to FDA 510(k) with our Sponsors.
Does anyone know what is required for this type of change? Our Sponsors differ in their approach and we do not know which is correct. One Sponsor has suggested that it is simply a notification letter to the ARTG (with FDA Decision Letter as a supplement) whereas the other has implied that it will require a full application (with various documents as supplement, e.g. DoCs, EPC, Risk Management documents, etc.) followed by a 12-15 week review by the ARTG to issue the updated Certificate.
Any information to help us conclude which Sponsor has the correct approach would be greatly appreciated.
Thank you!