Do AI medical devices need clinical data for CE mark? Many teams building AI that predicts, measures, prioritizes, or triages ask whether prospective clinical data is required under the EU MDR. Dr Ankeet Tanna outlines when clinical investigations are essential, when indirect clinical benefit and non‑clinical evidence can be enough.

Buying AI-triage software isn't like purchasing regular tech. These tools are medical devices with strict regulatory requirements. Our guide (co-produced with Visiba Group) breaks down everything you need to know…

From scribes and image analysis to triage, diagnosis, and treatment planning, the technical capability emerging from startups is already there. What’s less clear is a credible plan for how these tools will enter regulated clinical markets - and remain there.

While regulatory developments in the US, UK, and EU, such as the FDA’s AI January 2025 draft guidelines and the EU’s AI Act, have set prominent benchmarks, significant innovation and diverse regulatory strategies are evolving rapidly across Asia, Africa, and South America.

ISO and IEC standards are applicable to every industry, not just healthtech. But healthtech has its own standards that SaMD and AIaMD developers need to conform to.

Following on from previous blogs, What you need to know about traceable requirements for medical devicesand How much documentation does my Software as a Medical Device regulatory submission really need?, it’s time to now think about how to organise the complementary risk management, particularly for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

Anyone dealing with regulatory hurdles goes through the same 5 stages - denial, anger, bargaining, depression and acceptance. Here's how to smooth the journey.

In an industry where patient safety and regulatory compliance are non-negotiable, making unverified or misleading claims isn’t just bad practice – it can lead to hefty fines, product recalls, and serious reputational damage.

Once a device has been approved by an approved body in the UK, the question then becomes, how can a member of the public find out if a device is approved for use, and what it is approved for? Indeed, can we find out how many AI medical devices are actually on the market in the UK?

Guided by Hardian Health’s regulatory expertise, UCL spin-out Guildford Street Laboratories (GSL) has achieved a landmark milestone with their blood-based test, PD Predict, receiving FDA Breakthrough Device Designation

In part 1, we outlined the key concepts of a quality management system (QMS), explored what a QMS is – and what it is not – discussed why a QMS is required by law and who needs it, and provided an overview of the structure of a QMS. Now, in part 2, we'll move on to the practical side of implementing and managing a QMS effectively. Now then, back to Kipling’s six honest men…

Last month we hosted our third Health Tech Summit, bringing together our healthtech community at the London Institute for Healthcare Engineering for an afternoon filled with engaging discussions, expert insights, and canapés with a view!

As AI is increasingly integrated into more and more medical devices, the regulations and standards are also maturing and developing. Often we get asked ‘What are the most important standards we need to know?’, so here is the definitive list.

QMS. Three simple letters that often instil fear and dread into healthtech developer’s minds. It needn’t be that way! A well-designed Quality Management System will not only ensure your company is compliant with the relevant legislation, it will actually enhance and improve your internal processes so that your whole team feels in control of the quality of your products.

Find out how Hardian is supporting Innovate UK’s Mindset Extended Reality (XR) for digital mental health programme as part of Health Innovation Network (HIN) South London’s consortium of experts.

Current hot topics in clinical AI include clinical summarisers and ambient scribes. Poised to revolutionise the practice of clinical documentation, these technologies hold significant potential benefits, but also risks. This raises the question is - do they count as medical devices, and should they be regulated as such?

A key piece of the technical documentation for a medical device is a requirement stack that covers the total product lifecycle (TPLC) of that device, including the requirements.

It goes without saying (or you’d think so anyway) that strategic planning goes hand in hand with medical device development for regulatory approval and market success. However, it is often overlooked.