Creating a global regulatory intelligence database
Healthcare professionals and regulators across the world are used to having detailed information about the drugs available on market through well-structured and openly available formularies. Unfortunately, purchasers and procurers of medical devices have no central database or authority to rely on when to comes to deciding what devices to use, or even how to use them. The problem lies with regulatory databases… or to be specific, their lack of transparency and utility.
The information gap
As part of the UK government funded Centre of Excellence for Regulatory Science & Innovation for AI (CERSI-AI), Hardian has been researching the regulatory intelligence space and building a unified global database for every single medical device on the planet (over 8 million of them and counting). This is no small feat, when you consider that most countries don’t even have a database of registered devices, and those countries that do only share fairly limited data.
As a regulatory consultancy focussed on software devices, our initial aim was to identify and track all Artificial Intelligence devices on market. However, we quickly realised that to solve the transparency problem for AI medical devices, we would first need to solve the transparency problem for ALL medical devices.
This led us down a rabbit hole of UDI’s, GMDN codes and murky regulatory policies across the world…
In a nutshell, you may be surprised to know that there is NO globally recognised format for authorities on how they should share regulatory information for the regulated products that they oversee. Various different jurisdictions have come up with their own versions of a product database, with varying degrees of transparency. In the table below, we break down the five most ‘advanced’ regulatory jurisdictions by their key regulatory data criteria.
| Country | UK | EU | FDA | Canada | Australia |
|---|---|---|---|---|---|
| Regulatory Authority / Database | MHRA-PARD | EUDAMED | FDA | Health Canada | TGA - ARTG |
| Unique Device Identifier | ✖ | ✔ | ✔ | ✖ | ✖ |
| Device name | ✖ | ✔ | ✔ | ✔ | ✖ |
| GMDN / EMDN availability | ✔ | ✔ | ✔ | ✖ | ✔ |
| Device manufacturer | ✔ | ✔ | ✔ | ✔ | ✔ |
| Manufacturer Addresses | ✔ | ✔ | ✔ | ✔ | ✔ |
| Manufacturer contact details | ✔ | ✔ | ✔ | ✔ | ✔ |
| Intended Use Statement | ✖ | *✔ | ? | ✖ | ✔ |
| Warnings | ✖ | *✔ | ? | ✖ | ? |
| Contraindications | ✖ | *✔ | ? | ✖ | ? |
| Intended Use Population | ✖ | *✔ | ? | ✖ | ? |
| Date of approval / clearance | ✔ | ✔ | ✔ | ✔ | ✔ |
| Device classification | ✔ | ✔ | ✔ | ✔ | ✔ |
| Applicable legislation | ✖ | ✔ | ✔ | ✔ | ✔ |
✔ = Data is available in a structured format from the regulator. ✖ = This data is not available from the regulator. ? = This data may be available, if provided by the manufacturer (e.g. in a 510(k) summary) but is not routinely provided in a structured form from the regulator for every device. These are not necessarily required fields from the regulator, but may appear in the intended use statement for a device. * This is an available field when adding results to EUDAMED - this is scarcely used at the moment, but expected to improve when EUDAMED registration becomes mandatory in May 2026. MHRA PARD
Unfortunately for the UK, the MHRA comes very much last in this comparison, since (for some reason obscure to us) they chose not to even publish the NAME OF ANY DEVICES on their PARD database. This makes searching it almost entirely useless. You have to know the exact name of the manufacturer, and even then, you don’t get any useful information - just whether they have a device on market, and what risk class it is. If the manufacturer has several devices registered, then there is absolutely no way of telling which device is which. Even worse, there is no device information in regards to its intended use, contraindications or warnings, and the MHRA cannot tell you whether the device is authorised under the EU MDD, the EU MDR or the UK MDR, which is fairly important information considering the weird post-Brexit situation we find ourselves in. Nil points to the MHRA.
Health Canada
The Health Canada database is only very slightly better, since you can actually find device names, but without a UDI or GMDN code, it is hard to link specific devices to other regulatory information. Again the IUS is missing, as well as warnings and contraindications.
Australian ARTG
Weirdly, through the ARTG the TGA provide the intended use of individual products, but NOT necessarily the device name. Instead, what you get is the UDI and GMDN code, and often the name of the local consultancy or authorised rep who registered the device on behalf of the manufacturer with the TGA. Sometimes however you do get more useful information such as warnings and contraindications, especially if there is supplementary information upload in PDF format.
EUDAMED
Oh, poor EUDAMED. It’s taken over a decade and multiple millions of Euros to get us to the point of a barely functional, and extremely slow database. Rolled out over several years, module by module, this behemoth of a database on paper at least has everything you could want in regards to regulatory information. The problem is that it is so clunky and confusing, it feels like you are back in the late 90’s. Intended Use is currently an optional field, but future module roll-outs will make this a mandatory field at last.
US FDA
The FDA database is actually split into 27 different databases - but at least they all have useful information. There’s one for Premarket Notifications, one for PMAs, one for De Novos, and then separate databases for adverse events and reporting malfunctions, and even specific databases for different product types, product codes… and the list goes on. Separate to all this the FDA also publish quarterly their list of AI devices. So, while the FDA provides the most comprehensive data on medical devices, often with full summaries that include intended use and clinical performance data, it’s a bit of a nightmare tracking it all down.
Making it all make sense
Wouldn’t it be wonderful if all of this regulatory data for each and every medical device could be found in one place, under one common format?
Wouldn’t it be great if anyone, anywhere in the world could search for any device, and instantly get all the details they need? From device name, UDI, intended use, adverse events, clinical evidence, manufacturer details, and more, we think a unified global database is what the regulatory world needs.
That’s exactly what we’re building with our global regulatory intelligence database HaRi (which stands for Hardian Regulatory Intelligence). We’ve already launched a Beta version for public testing - this was a very simple proof-of-concept to help us understand how to better design a common format for intelligence data. Our Minimally Viable regulatory data format is listed below, with a rationale for each data field. (If you’re a regulatory authority reading this list - please, please do make every effort to ensure these minimal data points are publicly available - thank you!)
| Data field | Rationale |
|---|---|
| Device name | Without this crucial piece of information, it is not possible to know which device is which, making any regulatory intelligence impossible. |
| Unique Device Identifier | UDI is now mandatory across several jurisdictions, and helps identify devices and their versions - a key data point, especially for software devices that undergo several iterations. |
| Product status (e.g. date of expiry) | Purchasers should be able to know if the device they have procured has any status requirements, such as a conditional authorisation, or has a time limit for use. |
| Manufacturer name | Linking the manufacturer name to a specific device is crucial in assessing overall compliance, as well as tracking other regulatory indicators. |
| Manufacturer contact details | Important for reporting adverse events, errors and issues, as well as for regulators wanting to get in contact with manufacturers. |
| Intended Use Statement / Instructions for Use | The IUS is the key driver that determines both qualification as a medical device and its risk classification. Often manufacturer claims can differ from the regulatory-authorised intended use, so it is vital that the IUS is documented properly. IFUs shoud already be public from manufacturers. |
| Intended Use Population | Procurers need to be able to understand if a device is suitable for their population. |
| Contraindications / Warnings | As for any product, the key contra-indications and warnings are a must have - especially for medical devices where specific contra-indications may preclude certain populations or clinical environments. |
| Evidence (clinical efficacy & effectiveness) | Procurers want to be able to assess products on their clinical data. Currently very few regulatory authorities mandate disclosure of clinical performance data, regarding it as 'business sensitive'. Procurers are more likely to purchase devices with strong and transparent evidence, rather than those that chose to keep their evidence a secret. |
| Device Labelling | Nice to have - the specifics contained within device labeling give a lot more detail which can be useful for procurers and regulators. |
| Clinical investigation ID | Nice to have - many devices, especially higher risk devices, will have undergone a pivotal study or trial. Linking the clinical investigation ID (e.g. ClinicalTrials.gov ID) to a regulatory authorisation helps with transparency around clinical performance. |
| Manufacturer website / URL | Nice to have - many manufacturers have flashy websites (sometimes with overblown claims...) so linking a product website to its regulatory information helps regulatory authorities and procurers check that claims are indeed valid. |
We’re excited to bring the next version of HaRi to life in 2026. We plan on launching a fully functional public version of HaRi that allows for so much more functionality. We’ll keep adding data from other jurisdictional databases (such as SwissMedic, Brazil and China) to continue making HaRi more and more useful on a global scale.
HaRi will be available for simple search globally for free, with a paid subscription tier for those who want the advanced functionalities listed below:
Intelligent search - search for specific intended use, populations or compliance status, not just device or manufacturer name.
Build and save multi-device searches (useful for literature reviews etc).
Curate a portfolio of devices (useful for procurers who have a fleet of devices they need to keep tabs on, or a ‘wish list of products to compare).
Receive custom alerts for new information on your selected devices. (e.g. find out if a device you use had an adverse event in other country - you would never know this under the current system).
Predicate chain analysis - find out more about entire chains of ‘similar devices’ including linked adverse events and recalls.
Manufacturers can ‘claim’ their devices and to add further information such as product brochures and sales materials and link to their sales websites, with cross-site tracking.
Compliance and certification document upload for manufacturers.
Integrated peer-reviewed evidence and trial registry search so manufacturers can link their evidence, and procurers can check the evidence meets their criteria.
Many countries around the world currently have no central database for their medical devices, and HaRi could be the platform they decide to use, leapfrogging them into the modern era of regulatory innovation. Our hope is that by raising the veil of transparency across all medical devices, the entire industry can benefit.
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Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
