Rebecca Flint, Devices patient safety manager at The Medicines & Healthcare products Regulatory Agency, provides an overview of the medical device directives and regulations, as well as insight into the role of MHRA.
The Medicines & Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. As an executive agency, sponsored by the Department of Health and Social Care, it’s recognised globally as an authority in its field. The agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.
Responsible for ensuring that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy, MHRA’s Rebecca Flint, discussed the Medical Device Directive (MDD) and the new Medical Device Regulation (MDR) during her talk at the Theatres and Decontamination Conference in the Marriott Forest of Arden.
The MDR and In vitro Diagnostic Medical Device Regulations (IVDMDR) replace the current MDD, Active Implantable Medical Device Directive (AIMD) and the In vitro Diagnostic Medical Device Directive (IVDMD).
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