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Different IFU Requirements for Medical & Vitro Diagnostic Devices in the EU
The instructions for use (IFU) pertaining to medical devices substantially differ between the Medical Device Regulation (MDR) and the Medical Devices Directive (MDD). Despite the distinction, however, their IFU should demonstrate an economic operator’s (EO) conformity with technical requirements to ensure medical devices in the market are safe to use. We explained IFU requirements in […]
