How many AI-enabled medical devices are approved for use in the UK?
Within the United Kingdom (UK), medical devices, including AI enabled medical devices, are regulated under the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). 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?
To begin, let’s look beyond the UK to other regulatory jurisdictions. In the USA, the FDA has published and regularly updates a list of cleared AI-enabled medical devices. As of the publication of this article (January 2025), there are 1,016 AI-enabled medical devices cleared for use in the USA. Easy.
Within the EU, the EU MDR mandates that manufacturers register their devices on the European Database on Medical Devices (EUDAMED) when approved. Whilst this clause of the EU MDR is yet to be enforced (expected to begin in Q1 2026), in the near future manufacturers will be mandated to register all approved medical devices within the EU. Whilst the European Commission does not publish an updated list themselves like the FDA, using a combination of the “Device types” and “Nomenclature code” filters on EUDAMED, followed by manual filtering of the devices, it is possible to ascertain the number of approved AI-enabled devices certified for use in the EU (when the use of EUDAMED is enforced). This process is more convoluted than in the USA, but possible nonetheless.
How to find out if a device is approved for use in the UK?
Within the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA), the competent authority in the UK, hosts data on the Public Access Registration Database (PARD). This database allows a search by manufacturer, MHRA reference numbers, GMDN (Global Medical Device Nomenclature) codes, and medical device type or classification, and you would think that this will enable you to find out which device is approved for use in the UK. Well, sort of...
GMDN codes are 5-digit identifiers which categorise medical devices. They link to standardised terms describing the device, such as "Syringe, single-use." GMDN codes are used internationally by regulators, including the MHRA and the FDA (the EU, however, utilises European MDN codes (EMDN) which are specific to EU MDR and IVDR). However, there are currently no GMDN codes specific to AI, so using these to identify AI-enabled devices isn’t yet possible.
As stated on PARD itself “Brand/Trade/Proprietary names of registered devices are not currently displayed on PARD”. As such, the limited other information provided by PARD makes it difficult to understand which devices are approved to be used in the UK, and what these devices are approved for.
Let’s follow an example below…
Siemens, a German multinational conglomerate, manufactures, amongst other products, hardware and software which class as medical devices. Searching Siemens, on PARD returns 1246 registered medical devices. Adding “Class IIa” as a further filter, we are left with 17 registered GMDN codes and limited other information. Some examples of the registered GMDN codes can be seen below:
Cardiovascular ultrasound imaging system,
CT system application software,
Breast ultrasound imaging system, and
X-ray image interpretive software.
What we can see is that the GMDN codes could encompass a wide number of devices, and when just using the PARD data alone, it would be impossible to identify exactly which device (by name, or UDI) is registered for use in the UK, let alone how many of these are enabled by AI.
So when it comes to answering the question of “How many AI-enabled devices are approved for use in the UK”, the answer is … we don’t know and we have no way of finding out.
What do we need?
The inability to identify AI-enabled medical devices approved or registered in the UK is symptomatic of the wider post-Brexit instability of the current medical device regulatory landscape in the UK. The MHRA does not have the appropriate resources to maintain a database with functionality comparable to the EU or USA.
The MHRA has recently published its guidance on International Recognition, whereby products certified already in certain other jurisdictions can have a fast-track review in the UK. The acceptable approvals from regulatory bodies include:
Therapeutic Goods Administration (TGA) - Australia,
Health Canada - Canada,
SwissMedic - Switzerland,
Health Science Authority Singapore (HSA) - Singapore,
Pharmaceuticals and Medical Devices Agency (PMDA) - Japan,
Food and Drug Administration (FDA) - United States, and
European Medicines Agency (EMA) and Member State Competent Authorities of the EU, Norway, Iceland and Lichtenstein - European Union/European Economic Area.
There are caveats for certain clearance processes (e.g. 510(k) authorisations for software as a medical device in the United States, will not be accepted by the MHRA), but it’s easy to see the importance of being able to identify and match unique devices in the UK, to those internationally approved. Whilst unique device information will likely be supplied to the MHRA during this assessment, it is imperative that the unique device information and intended use is available to the public after a device has been approved. Without it, patients, clinicians, insurers, funders, and any member of the general public cannot reasonably ascertain if a device they want to use or prescribe is legally allowed to be used within the UK, or for what purpose.
At Hardian Health, we are building HaRi: Hardian’s regulatory intelligence. Still in beta at the time of writing, we aim to put together publicly available information about approved medical devices to give us all a clearer picture of what device is registered, for what intended use, and in which jurisdiction.
If you’d like to get involved in how we are redefining the access to data, reach out to the Hardian Health team below.
