|Theme||Obligations of persons referred to in Article 16|
|Target audience||Persons referred to in Article 16|
|Products concerned||MD, IVD|
|Regulatory references||MDR (EU) 2017/745
IVDR (EU) 2017/746
This guide provides additional information on if the event that a distributor, importer or other natural or legal person fulfils the obligations incumbent on manufacturers if he carries out certain activities.
This document specifies that economic operators carrying out the activities mentioned in Article 16 point 1 must register as manufacturers in EUDAMED, receive a unique registration number (SRN), follow the appropriate conformity assessment procedure and register the device’s UDI.
The distributor or importer carrying out the activities referred to in Article 16 point 2 (a) and (b) shall ensure that these activities do not in any way compromise the readability of the UDI carrier and the information identifying the device. Moreover, these specific procedures must be part of the distributor’s or importer’s quality management system.