Written by IMed Consultancy – a leading provider of expert services to the global medical health technology industry, launches today a free whitepaper exploring guidance and on latest regulatory framework for classifying and bringing digital mental health technologies (DHMTs) to market.
As rates of depression, anxiety, insomnia and related disorders rise globally, the demand for accessible and effective mental health support has never been greater. The World Health Organization (WHO) estimates that almost 4% of the global population will suffer from depression at some point in their lives. Such pressing demand has accelerated fast-paced innovation in the field of digital mental health, leading to confusion about regulatory obligations and blurring the line between lifestyle trackers and real medical devices. In particular, their integration of Artificial Intelligence (AI) and Large Language Models (LLMs) for diagnostic and treatment purposes, poses a series of regulatory concerns that need to be addressed to ensure safe, positive patient outcomes.
The whitepaper, Mental Health goes digital: a blueprint for Digital Health Medical Technologies (DHMTs), provides a detailed overview of the new guidance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), helping developers determine whether their digital tools should be regulated as medical devices, or not. It offers practical insights into the classification criteria, regulatory pathways, and evolving expectations for AI-powered tools, including those incorporating large language models and generative AI.
“Digital mental health technologies respond to an urgent need and are reshaping how care is delivered, but innovators must navigate an increasingly complex regulatory environment,” said Jonathan Ripley, Managing Director at IMed Consultancy. “Our new whitepaper helps companies understand the latest MHRA guidance and prepare for successful, compliant market entry.”
As AI-powered tools become increasingly embedded in healthcare pathways, the MHRA’s move toward a more structured, transparent approach is a welcome development. By clarifying what constitutes a regulated medical device and setting expectations for safety, functionality, and clinical purpose, the guidance helps align innovation with patient safety.
“Understanding whether your digital mental health product qualifies as a medical device is of critical importance to users,” added Benjamin Austin, Senior QA/RA Consultant SaMD/AI. “Our goal is to equip innovators with the tools and knowledge to confidently bring safe, compliant, and effective technologies to market.”
Download your free copy today at https://imedconsultancy.com/ and ensure your innovation remains compliant, competitive, and ready to meet the needs of a rapidly evolving healthcare environment.
About IMed Consultancy
Founded in 2012, IMed Consultancy offers a wide range of expert services to the global medical and health technology industry. We support medical device and in vitro medical device manufacturers to drive innovation, improve patient care and outcomes worldwide, providing assistance through all stages of the product lifecycle from: from concept and design through clinical studies and post-market surveillance.
IMed Consultancy’s team of highly skilled and experienced medical regulatory professionals offers an outstanding yet accessible global regulatory service. We are committed to our team, to innovation, to our client’s growth and success, to the health tech community, and patients. We build trusted relationships by offering agile solutions and education to advance healthcare innovations and adapting flexibly to client needs as we strive to stay ahead of industry trends, investing in developing our knowledge and seeking new opportunities to deliver value to the sector. With over 70 years of combined hands-on problem-solving expertise, our remit is truly global, ensuring that client devices are successfully launched and maintained in total compliance in the UK, EU and internationally.
For more information visit www.imedconsultancy.com
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