CE Mark Conformity Assessment Annex II vs. Annex VII+

[cverg]

To clarify the EN ISO 14971 point: the notified body accepted ISO 14971:2007 when it was just for ISO 13485 certification, but for MDD compliance, we were required to update to the 2012 version.

I'm sure you are right about the cost analysis long term. Good thing for others to think about when choosing the route.

Thanks Ronen.