Relevant obligations arising from Article 16(1)
Any distributor, importer or other natural or legal person that assumes the obligations incumbent on manufacturers in accordance with Article 16(1), assumes all the relevant responsibilities related to UDI, including UDI labelling.
This means that those economic operators must also apply for registration as Manufacturers, receive a Single Registration Number (SRN), apply for the appropriate conformity assessment procedure and feed and provide UDI-product registration.