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We have a full quality system for our class IIa and IIb devices and as such our CE certification indicates compliance with Annex II of MDD 93/42/EEC. A while back; based on very similar products on the market, I realised that one of our IIa products should really be a class I device with a measuring function (Im). I notified our NB about this re-classification with the appropriate background/evidence for this change. Eventually (two years later!) they indicated that this product would require a separate certificate under Annex V (production quality system). If we have what seems to be a ‘higher’ level QMS why would this be necessary?