지침,참고문헌 | MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation (EU) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746

MDCG 2018-6_art16_en.pdf (297.8K) [25]

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.
However, in accordance with the provision of Article 16(1)a, when a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label, the manufacturer is responsible for meeting the requirements placed on manufacturers in this Regulation, including the relevant UDI obligations.