The product data exchanged by country is listed below. The document explains which data to enter in which attribute. Also indicated are the product data mandatory according to U.S. FDA and U.K. NHS.
There is an agreement document that focuses on a more efficient and practical guide in the implementation of the European directives MDR and IVDR and the Dutch LIR registration obligation and the Covenant on Safe Medical Technology for all parties involved in the Netherlands, namely manufacturers, importers, distributors, and healthcare institutions.
The purpose of this document is to establish the use and framework of a uniform dataset for all medical products used in Dutch healthcare institutions, integrated in GDSN, for the healthcare institutions affiliated with the NVZ, NFU and the manufacturers, importers and distributors affiliated with FHI, FME and Nefemed. We conform to the uniform dataset until it is fully incorporated into GDSN. These fields will also be integrated into the GS1 ECHO data model.
More information? View the 'Declaration of Intent Uniform Dataset' and the explanation of 'Why a Uniform Dataset'. Questions? Send an email to healthcare@gs1.nl.