My company manufactures class IIa medical devices following annex II of the MDD.
Our registrar of iso9000 and iso13485 is also our notified body for CE mark.
But our NB can't mark class III devices.
My question is if we can use the company certification to ISO9000 and iso13485 (released by our actual NB) to mark ce the class III device following Annex II but using a different NB that is authorized to certify class III device.
If the answer is yes what kind of activity we have to manage with this new NB? I think that this NB have only to make the examination of the design dossier of the Class III medical device.
Our registrar of iso9000 and iso13485 is also our notified body for CE mark.
But our NB can't mark class III devices.
My question is if we can use the company certification to ISO9000 and iso13485 (released by our actual NB) to mark ce the class III device following Annex II but using a different NB that is authorized to certify class III device.
If the answer is yes what kind of activity we have to manage with this new NB? I think that this NB have only to make the examination of the design dossier of the Class III medical device.