One non-EU auditor of our NB says the followings, based on inspection of the designation competent authority:
(1) The CE mark with NB identification number can be affixed to the device only in one place for each device that the manufacturer applied to NB, and
(2) Classification is required for each device that the manufacturer applied to NB.
I cannot find the requirements of (1) and (2) in MDR, and there are the following problems in satisfying the requirements of (1) and (2).
(A) In case of that a system product consists of multiple trade items, since customs clearance is not possible without the CE mark for each trade item of the system product and Article 20(5) of MDR says "Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52.", the non-EU manufacturer substantially must apply to NB for each trade item of the system product as a device, although previously the non-EU manufacturer was allowed to apply to NB for each system product as a device. (This makes that it is necessary to list a large number of devices in the application.)
(B) When the classification rule is applied for each trade item of the system product, the applied classification rule and the classification may change as a result. When the classification is changed to Class I, compliance with MDR Annex I becomes indispensable, and it becomes necessary to change the CE mark with NB identification number to the CE mark without NB identification number.
Could you let me know whether or not what this NB auditor says is appropriate and the reason why?
(1) The CE mark with NB identification number can be affixed to the device only in one place for each device that the manufacturer applied to NB, and
(2) Classification is required for each device that the manufacturer applied to NB.
I cannot find the requirements of (1) and (2) in MDR, and there are the following problems in satisfying the requirements of (1) and (2).
(A) In case of that a system product consists of multiple trade items, since customs clearance is not possible without the CE mark for each trade item of the system product and Article 20(5) of MDR says "Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 52.", the non-EU manufacturer substantially must apply to NB for each trade item of the system product as a device, although previously the non-EU manufacturer was allowed to apply to NB for each system product as a device. (This makes that it is necessary to list a large number of devices in the application.)
(B) When the classification rule is applied for each trade item of the system product, the applied classification rule and the classification may change as a result. When the classification is changed to Class I, compliance with MDR Annex I becomes indispensable, and it becomes necessary to change the CE mark with NB identification number to the CE mark without NB identification number.
Could you let me know whether or not what this NB auditor says is appropriate and the reason why?
