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See today's BioWorld MedTech
Home » EU hospitals must adopt a risk management system for in-house devices and diagnostics
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EU hospitals must adopt a risk management system for in-house devices and diagnostics

Jan. 17, 2023
By Mark McCarty
The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) each allow a hospital to develop a device or an in vitro diagnostic for use solely in that hospital, but there is no regulatory free pass despite the lack of commercial intent. While the latest guidance on these in-house tests acknowledges that the hospital must determine the degree to which it must comply with the relevant regulation, any hospital that makes and uses an in-house diagnostic or device must develop a risk management mechanism for that device or diagnostic, not an easy lift for entities that may be glancingly familiar at best with conventional regulatory schemes.
BioWorld MedTech Regulatory Europe

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