We have seen a growing number of companies come to Hardian after submitting a clinical investigation application, a Notice of No Objection, to the MHRA and receiving significant questions, an objection, or facing the prospect of resubmission.

The clinical study may be well thought through. The problem is that the documentation supporting the investigational device simply isn't at the level the MHRA expects.

The HEOR team of Hardian Health is offering a new service for digital health companies to support them with evidence generation when their products are evaluated post-market through randomised controlled trials.

Our new package involves the analysis of primary data to estimate health outcomes, costs, and Incremental Cost-Effectiveness Ratios (ICERs) for decision making. By leveraging primary data collection, health outcomes and costs derived from randomised trials can also be extrapolated as robust inputs for subsequent, post-market cost-effectiveness models.

In the UK, Class I SaMD and AIaMD products are self-certified, which means no UK Approved Body (or EU Notified Body), no ISO 13485 certification, and no third-party conformity assessment. In the US, 510(k) exempt devices also have no regulatory scrutiny from the FDA. Find out more about proportionate mini-QMS for these lower risk devices.

The vast majority of AI medical devices rely on having a clinician verify their outputs. On the surface this seems good for safety, but in reality it’s a short-sighted solution to a much deeper problem.

Pre-market review only interrogates AI device performance at a single point in time, often in laboratory conditions. This is a common yet completely valid criticism of the regulatory process. Therefore consensus amongst regulators and academics is that the real-world safety of AI devices must be monitored post-market in real time.

But is anyone actually doing it?

Software and AI medical devices (AI/SaMD) are solving clinical problems at speed. Healthcare systems, though, won't adopt a technology that works brilliantly if they can't make an economic case for it. At the Hardian Summit 2026, we hosted a workshop on Health Economics and Outcomes Research for professionals new to the field.

Computer software validation has never mattered more in the age of AI. Software now sits at the centre of most medical device quality systems. A medical device manufacturer may use software to track requirements, control documents, record complaints, manage CAPAs, train staff and maintain technical documentation.

From AI regulation to NHS adoption, here are the biggest insights from Hardian Health Tech Summit 2026 and what they mean for HealthTech companies.

Do you need MHRA Notice of No Objection for your SaMD study? Learn when NoNo is required, how to apply, and what documentation regulators expect.

A strong literature review shapes SaMD study design, from comparators to sample size. Learn how it reduces risk in pivotal clinical studies.

The NHS has long been a testing ground for innovation, but scaling new technologies has often been slower and fragmented. Now, NICE is changing HealthTech adoption in the NHS through a more structured and flexible approach.

We recently published a Systematic Literature Review (SLR) in European Radiology, developed in collaboration with Prof. Zanca at the European Commission, so we wanted to share our progress on developing best practice guidance for assessing the value of radiology AI.

Fertility tracking apps are widely used, but are they regulated as medical devices? The answer depends on functionality. Some apps that support conception or contraception fall under UK and EU medical device regulations, while others remain outside formal oversight. Understanding when fertility apps are regulated is essential for both users and developers navigating safety, data protection, and compliance.

ISO 14971 has been central to medical device risk management for over two decades. It provides a structured and defensible methodology: identify hazards, analyse hazardous situations, estimate and evaluate risk, implement controls, and determine whether residual risk is acceptable in light of clinical benefit.

Science washing in digital health can damage trust and trigger regulatory scrutiny. Learn how to communicate evidence responsibly and build credibility.

In July 2025, the FDA issued a warning letter to WHOOP, stating that measuring blood pressure is a medical device function. But in January 2026, they updated their guidance. What changed? Do the new guidelines really allow wearables to measure blood pressure without regulation or evidence?

It’s been 4 years since the FDA updated their CDS guidance. The new 2026 version brings clarification, more examples, and some pragmatic relaxation of how to interpret the CDS criteria. But are the changes really that substantial?

Many countries around the world currently have no central database of their medical devices, or have ones that are not quite fit for purpose. We are building HaRi - a global regulatory intelligence database - bringing medical device regulatory data into modern era of innovation. Our hope is that by raising the veil of transparency across all medical devices, the entire industry can benefit.