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In the 1990s, the European Union (EU) regulation of medical devices across the European Economic Area (EEA) was harmonized under three medical device directives
A proposed rule issued by the FDA pertaining to the unique device identification system likely foreshadows its mandatory implementation, as it is aimed at establishing compatible traceability systems between member states of the European Union
FDA is always criticized and questioned about taking longer to approve regulated products than its counterpart agency in Europe, European Medicines Agency (EMA
