29 July 2025 – BSI, a leading global Notified Body (NB), has completed its 50th AI systems review under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This achievement confirms BSI’s position as a trusted MDR and IVDR Notified Body, helping to ensure the effective integration of AI systems into medical devices globally.
Assessments have been carried out with manufacturers operating across 15 countries, including Europe, China, the UK, US and Australia. The 50th assessment was completed in June. BSI’s experts have assessed a wide range of devices, from MRI technology to dental software.
Manuela Gazzard, President, Regulatory Services, BSI said: “There has been a huge rise in the number of medical devices with AI technology in recent years, and whilst AI has the potential to drive a better future for organizations and patients, as with any new technology, it brings an element of uncertainty.
“Reaching the 50th AI review under the MDR and IVDR reflects our drive to remain at the forefront of regulatory innovation and continuous improvement in the face of evolving industry demands. Our priority is ensuring that across society people can benefit from these technologies safe in the knowledge that they can be trusted.”
Dr Michael Weissig, Global Managing Director Medical Devices, Regulatory Services, BSI added: “The EU AI Act marks a pivotal shift for medical devices incorporating artificial intelligence, and BSI is proud to be at the forefront of supporting our clients through this transition.
“With a broad and deep expertise in medical devices and in vitro diagnostics, combined with a highly experienced team of AI technical specialists spanning multiple industries, we’ve now completed our 50th assessment of an AI-enabled device within the last two years. This milestone underscores our leadership in the AI Assurance space and our commitment to guiding the world’s leading firms through the evolving regulatory landscape.”
As AI is growing towards becoming embedded in numerous products across multiple industries, it is increasingly vital that the regulatory system will be ready to ensure ethical and trustworthy applications of AI. BSI is proud to be at the forefront of this innovation, and we are working to ensure we are future-ready to embrace Artificial Intelligence. The Regulatory Services Division of BSI is currently working towards designation as an AI Notified Body.
