This position paper sits in the framework of the EU Medical Devices Regulation (MDR) and In-vitro Diagnostics Medical Devices Regulation (IVDR), and relates to mergers and acquisitions (M&A). It provides guidance on the relationship between the GS1 Company Prefix (GCP) in the Global Model Number (GMN) and the GCP in the Global Trade Item Number (GTIN).
This paper is for medical device manufacturers who use GS1 standards to identify products supplied to the EU market under the EU MDR and IVDR.
Main sections:
· Scope
· Definitions
· M&A and GMNs – Decision tree
· Reference documents and links
This paper is for medical device manufacturers who use GS1 standards to identify products supplied to the EU market under the EU MDR and IVDR.
Main sections:
· Scope
· Definitions
· M&A and GMNs – Decision tree
· Reference documents and links