Jun 8, 2021
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published guidance describing the registration process medical devices must go through before placing them on the market in Great Britain...
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Jun 3, 2021
Uncategorized
The Medicines & Healthcare products Regulatory Agency (MHRA or the Agency), the UK`s regulating authority in the sphere of medical devices, has published an updated version of its guidance dedicated to clinical investigations. The new version describes regulatory...
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Jun 3, 2021
MHRA
The MHRA has published a draft Patient Involvement Strategy describing how patients and the public should be involved in processes related to medical devices and other healthcare products. Table of Contents It is important to mention that a similar policy was already...
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Mar 16, 2021
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document dedicated to the in-vitro diagnostic (IVD) point-of-care test devices. Aside from other aspects, the...
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Mar 16, 2021
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the patient-reported outcome measures and the way they should be used in medical product development to support labeling claims. Together with the Patient Preference Information...
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