This European Standard specifies requirements and guidance for the construction of a nomenclature for medical devices in order to facilitate co-operation and exchange of regulatory data on an international level between interested parties such as: Regulatory Authorities, Manufacturers, Suppliers, Health Care Providers, and End Users. NOTE: This European Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases utilizing the nomenclature system described herein.
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