Economic operator

Each economic operator has its own obligations under the MDR or IVDR, and the rules on supply chain identification apply to all of them. Manufacturers, authorised representatives and importers register in EUDAMED, while distributors do not.

‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);

EU MDR, Article 2(35)

‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;

IVDR, Article 2(28)

The MDR list also includes the person referred to in Article 22(1) and 22(3), the producer of systems and procedure packs. The IVDR list has only manufacturer, authorised representative, importer and distributor.