United Kingdom

09/08/2022

Guidance on Medical device stand-alone software including apps (including IVDMDs) This guidance is applicable to standalone software and apps placed on the Great Britain market. The UKCA (UK Conformity Assessed) mark is used for certain goods, including medical devices being placed on the Great Britain market. This guidance gives examples of Software and Apps that meet the definition of a medical device and outlines requirements for UKCA marking medical devices.

10/25/2022

Implementation of the future regulation of medical devices and extension of standstill period UK MHRA has introduced a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024.

03/27/2023

Guidance on Registering medical devices to place on the market The guidance on Registering Medical Devices has made certain updates, including the review registration, making changes to your registration, public register of manufacturers sections, updated account management, and device registration reference guides.

04/01/2023

New statutory fees for MHRA services introduced from 1 April 2023 From Saturday, 1 April 2023, new fees are being introduced for a range of MHRA services to ensure the agency covers its costs and achieves financial stability in the years ahead. The new fees will enable the MHRA to deliver a responsive and efficient regulatory service that protects and improves patient and public health by facilitating access to high-quality, safe, effective, and innovative medical products.

04/06/2023

Guidance on Software and Artificial Intelligence (AI) as a Medical Device Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices (or as in vitro diagnostic medical devices (IVDs). This guidance provides access to important Software Group outputs that might be of assistance.

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