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.

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.

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?

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.

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.

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.

We're witnessing a rapid rise of the use of generative AI in the medical device regulatory space to produce and review documentation. This raises the question - If all compliance documentation is created by a machine, and all compliance documentation is audited by a machine - has any compliance actually happened?

MyCardium AI is a rapidly growing UK-based company delivering advanced core-lab services, now with two CE-marked and FDA-cleared AI medical devices - 1CMR Pro and EchoConfidence - built on decades of leading academic research. With Hardian Health as a strategic partner, MyCardium navigated complex regulatory pathways with exceptional speed and success. How did they do it?

Many healthcare software products are described as “platforms.” But when it comes to Software as a Medical Device (SaMD), regulatory challenges quickly emerge. From classification to conformity assessments, platforms that host or enable MDSW apps—particularly those involving AI—must navigate complex and evolving frameworks across jurisdictions like the UK and EU.

SaMD regulatory requirements are fast evolving, with international efforts to harmonise frameworks still taking shape. Yet manufacturers must navigate jurisdiction-specific rules—especially as the US aligns more closely with ISO 13485:2016 in its Quality System Regulation. Whether you're targeting EU, US, or emerging markets, understanding the SaMD regulatory landscape is a critical first step.

Recently, we hosted an exclusive webinar featuring Dr Vera Roedel (CEO) and Professor Heinz Wiendl (Co-Founder) from Prof.Valmed®. They have achieved the significant milestone of securing the world's first regulatory clearance for a large language model (LLM) as a medical device.

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…