- Global Pharma News & Resources


London, U.K., Wednesday 15 September 2021: Healthtech Limbic has achieved a Class 1 UKCA mark. 

The mark, which recognises that Limbic conforms with all legal requirements in the UK MDR 2002, has been awarded for Limbic Access, the organisation’s software that augments clinical assessments in mental healthcare services. 

In achieving UKCA Class I, Limbic has aligned it’s software development processes and architecture to meet the safety and performance requirements for software as a medical device as part of the UK MDR and European Directive 93/42/EEC on Medical Devices.

Limbic’s medical device status is predicated on the use of Limbic Access by mental health services, reinforcing evidence that Limbic Access makes it easy for patients to refer to local mental health services, provides a better and more engaging patient experience and creates efficiencies in the clinical pathway. 

Limbic Access is currently the only UKCA marked software delivering self-referrals in NHS Improving Access to Psychological Therapies (IAPT) services. It is one of four platforms that Limbic has released, all of which are designed to ease pain points in the clinical pathway:

  • Limbic Access (Class 1 UKCA mark) - clinical assessments tool for self-referrals 
  • Limbic Self-Care - instant CBT support for patients on the waitlist 
  • Limbic Care - personalised support and remote monitoring for patients in treatment
  • Limbic Prevent - personalised relapse prevention post-treatment

Dr Ross Harper, CEO and Co-founder of Limbic commented:

“We are thrilled to have achieved a UKCA mark in such a short period of time. At Limbic, not only do we strive to build market-leading technology, but we also aim for the highest level of rigour. Receiving a UKCA mark means our customers can be entirely confident that our team is taking all the right steps to properly build and test our products to the highest possible standards.”

Editor Details

Related Links

Last Updated: 23-Sep-2021