European Commission Clarifies UDI Manufacturer Obligations

Distributors and importers that assume the obligations of device manufacturers also assume responsibility for unique device identification labeling, the European Commission said.

Distributors and importers must apply for registration as manufacturers and receive a single registration number, according to Article 16 of the EU’s Medical Device Regulation.

The entities would apply for the appropriate conformity assessment procedure and provide UDI-product registration, the Commission said in five new guidances.