The article provides an overview of the regulatory policy to be applied to software products and highlights the key points associated thereto. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority, has published...
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulating authority, has initiated a public consultation regarding the regulatory framework for medical devices. In particular, the authority encourages medical device manufacturers and other...
Previously we released an article dedicated to the regulatory framework for medical devices introduced under the Medicines and Medical Devices Act 2021 (the Act), the key element of the UK legislation on medical devices. The present article is dedicated to the...
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...
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...