Europe
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...
Europe
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...
Europe
The UK Medicines & Healthcare products Regulatory Agency (MHRA), the country’s regulating authority in the sphere of medicinal products and medical devices, has published a guidance document dedicated to the equipment for temperature screening intended to be used...
Europe
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...
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...
