Europe
The Medicines and Medical Devices Act 2021 (the Act), adopted on February 11, 2021, constitutes one of the basic elements of the UK`s legislation in the sphere of medical devices. The document outlines the rights and responsibilities of a Commissioner of Patient...
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...
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...
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...
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has published guidance dedicated to the medical device stand-alone software including applications. The scope of the guidance covers standalone software and applications intended to be marketed...
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published updated guidance on in vitro diagnostic (IVD) medical devices intended for point of care use. The initial version of the...
