EBO Announces MHRA Registration of Clinical Management Support Software as a Class I Medical Device 

EBO Announces MHRA Registration of Clinical Management Support Software as a Class I Medical Device

EBO is pleased to announce that its ‘Clinical Management Support Software’ has been successfully registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a Class I medical device. 

The registration marks a significant milestone for EBO, reinforcing the company’s commitment to delivering trusted, compliant, and clinically focused patient engagement solutions powered by Generative AI. 

Addressing a Growing Challenge

As healthcare organisations, such as the NHS, continue to face increasing operational complexity and growing patient demand, EBO’s AI-powered patient engagement solution plays a critical role in supporting efficiency, consistency and quality of care.  

EBO supports healthcare providers to manage clinical workflows and patient interactions more effectively. Our core mission is to remove friction from patient communication, reduce administrative burden and improve access to healthcare.  

Safety, Discipline, and Commitment to Quality

The MHRA registration strengthens EBO’s position in clinically governed AI, confirming that its technology has been developed within an established regulatory framework that supports robust governance and risk management. 

It demonstrates EBO’s safety standards and commitment to quality, while also reducing adoption friction for healthcare providers and supporting broader NHS deployment. 

The registration further underscores EBO’s dedication to patient safety, reflecting the rigour with which the company designs, documents, and maintains its software in line with medical device regulations. 

EBO’s latest Solution

EBO's solution interface

Built in line with UK medical device regulatory requirements, EBO’s solutions help patients access and navigate their healthcare journeys with greater ease. Among its latest innovations is the Single Point of Access and Navigation (Project S.P.A.N), which creates a safeguarded digital front door for neighbourhood and community services. The solution gives patients and carers a clearer route to the right service the first time, reducing avoidable calls, emails, redirections, and manual signposting. 

Project S.P.A.N brings together approved local guidance, service catalogues, referral criteria, appointment instructions, and NHS content to generate a single, patient-friendly answer in plain language, delivered conversationally through secure, guardrailed Generative AI. 

Commenting on the registration, Dr. Gege Gatt, EBO’s CEO, says:

"This registration is more than a regulatory milestone, it's validation of the rigour we've built into our technology from day one. Patient safety and clinical governance have always been at the heart of how we design and deploy AI, and this recognition confirms we're meeting the highest standards expected in healthcare, particularly as we embed guardrailed Generative AI even more deeply into our solution. It positions EBO as a genuine partner in solving some of the NHS's most pressing challenges." 
Gege Gatt EBO's CEO
Dr. Gege Gatt
CEO, EBO

Looking Ahead

The MHRA registration strengthens EBO’s position in the digital health sector and supports the company’s continued growth across the UK healthcare market. 

⇒ For more information about EBO and its AI-powered solution download our free guide or contact us 

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