Strategies and roadmaps
Roadmap towards the future regulatory framework for medical devices
“This roadmap provides an update on the intended timelines to implement the future core regulations. 28 countries from across the…
Regulatory body
Reports, resolutions, and position papers
Overview of the CMA’s provisional approach to implement the new Digital Markets competition regime
“This overview responds to a request from ministers from the Department for Business and Trade (DBT) and the Department for…
Regulation and official guidance
How to use AI and personal data appropriately and lawfully
Increasingly, we are seeing an uptake in applications of artificial intelligence (AI). The use of AI has the potential to…
Regulation and official guidance
Guidance on GxP data integrity
The guidance is intended to be a useful resource on the core elements of a compliant data governance system across…
Regulation and official guidance
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…
Frameworks and principles
Predetermined change control plans for machine learning-enabled medical devices: Guiding principles
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles…
Regulation and official guidance
Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system
Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…
Research and analysis item
The benefits and harms of algorithms: a shared perspective from the four digital regulators
In 2021 the DRCF established an Algorithmic Processing workstream to explore the impact of algorithms across our industries and regulatory…
Research and analysis item
Auditing algorithms: the existing landscape, role of regulators and future outlook
In 2021 the DRCF established an Algorithmic Processing workstream to explore the impact of algorithms across our industries and regulatory…
Research and analysis item
Using machine learning in diagnostic services: a report with recommendations from CQC’s regulatory sandbox
This report presents the findings from the Care Quality Commission’s (CQC’s) regulatory sandbox pilot. Regulatory sandboxing is a way of…
Strategies and roadmaps
Online safety bill: Ofcom’s roadmap to regulation
Official policy proposals and consultations
