The Important Role of a PRRC in Medical Device and Software Compliance

Åsa Möllby Director, Medical Device Quality Assurance – GBA Key2Compliance One of the changes introduced by the Medical Device Regulation (MDR) in 2017 and the In Vitro Diagnostic Device Regulation (IVDR), is the requirement of a designated Person Responsible for Regulatory Compliance (PRRC). A PRRC bears the important role mandated by the MDR and IVDR […]

2024 To-Do list for legacy devices transitioning to MDR

The European Commission published Regulation (EU) 2023/607 in early 2023 which specifies conditions for extending the deadlines for medical device manufacturers transitioning from MDD to MDR and removing the “sell off” period. The regulation was published to minimize impact on healthcare services caused by device shortage, to prevent unnecessary disposal of safe devices and to […]

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