1. Medtech Insight
  2. >>Digital Technologies
  3. >>AI

UK’s NHS Launches AI Regulation Service Specifically For Medtech Firms

 
• By Eliza Slawther

The regulatory landscape for digital and AI-based products can be tough for companies and users alike to navigate. Four UK organizations have partnered up to create a service that aims to demystify complex regulatory rules around AI and digital medtech.

AI Regulation
• Source: Shutterstock

The AI and Digital Regulations Service was recently launched to assist stakeholders − from product developers to patients − in understanding the UK regulatory requirements for AI and digital health products.

The service is designed to be a one-stop shop for understanding how AI and digital medical device regulation, standards and guidelines work in the UK

Much of the UK’s medical device and AI regulation remains under development and will presumably appear on the AI and Digital Regulations Service list in due course. Medical devices that are CE marked under the EU Medical Device Regulation (MDR) will be recognized in Great Britain until 30 July 2024, after which products must be Conformity Assessed (UKCA) marked.

In October, the MHRA announced its plans to introduce “legislatively light” AI regulation compared to the EU proposals for a heavy, horizontal regulation known as the AI Act.(Also see "

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from AI

Subsense Develops Nonsurgical, Nanoparticle-Based Brain-Computer Interface For Neurological Disorders

 
• By Marion Webb

Neurotechnology start-up Subsense came out of stealth with $17m in seed funding to develop a nonsurgical, nanoparticle-based brain-computer interface. Medtech Insight spoke with the firm’s new neurotech lead Cyril Eleftheriou about the technology and its potentially wide applications for treating Parkinson’s, epilepsy, inner speech decoding, and more.

AAOS 2025 Orthopedic Roundup: J&J Velys UKA, Stryker Mako 4, Materialise, Canary Medical

 
• By Marion Webb

At AAOS, orthopedics players showcased their latest robotic-assisted platforms, power tools, 3D printed technologies and software offerings. This article brings you highlights from interviews Medtech Insight conducted on site with representatives from J&J, Stryker, Materialise and Canary Medical.

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 
• By Natasha Barrow

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

More from Digital Technologies

Abbott Embeds Libre Glucose Data In Epic EHR, Expanding Digital Health Footprint

 
• By Shubham Singh

Through this partnership, data stored in LibreView – Abbott’s cloud-based diabetes data management system – can automatically flow into Epic, allowing clinicians using Epic to view a patient’s CGM data before, during and after visits without toggling between systems or requesting manual uploads.

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 
• By Natasha Barrow

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.