Abstract:

Driven by the desire for international harmonization, the IMDRF (International Medical Device Regulators Forum) was established in 2011 by approval authorities from Australia, Brazil, Canada, China, the European Union, Japan, the USA and WHO1. The Global Harmonization Task Force for Medical Devices (GHTF) is involved in this project. The European (EU) activities are linked to other mentioned international regulatory areas, in particular with the activities of the FDA. For manufacturers exporting to the US, it is already mandatory to comply with UDI (unique device identifier) and FDA’s GUDID (Global Unique Device Identifier Database) and consequently to manage device master data in ERP software and QMS. The European pendant to GUDID will be EUDAMED (European data bank for Medical Devices) which is still under construction. However clinical researchers for medical devices should already be aware right now about the similarities and differences between both systems and the operational consequences.