Frequently Asked Questions

HaRi stands for “Hardian Regulatory Intelligence”. HaRi is a global regulatory intelligence platform that unifies data from the world’s major medical device databases into a single, searchable interface. We help regulatory professionals, healthcare procurement teams, and manufacturers find and share information on devices, safety events, and market status without having to toggle between multiple regulatory and government portals.

Accuracy is our priority. We use source-faithful normalisation, meaning we clean and organise the data for better search-ability without altering any original regulatory data. Every result includes a direct link to the original source record so you can verify the details yourself.

HaRi was built under ISO 9001:2015 (Quality Management) and ISO/IEC 27001:2022 (Information Security), ensuring that our data handling and platform security meet the highest international standards. We also conduct regular penetration testing.

HaRi is funded by CERSI-AI, The Centre of Excellence for Regulatory Science & Innovation in AI & Digital Health, in combination with UKRI, the MHRA, DoH, OLS and DSIT. Additional funding has been self-funded by Hardian Limited.

HaRi is built and maintained by Hardian Limited as part of a multi-disciplinary project to increase regulatory transparency across the globe.

User fees help recoup running costs as part of the funders' mandate for sustainability of the CERSI-AI consortium.

HaRi Pro is designed for users who need to monitor the market or a deployed fleet of devices actively, or conduct and save multiple searches. Pro features include:

Bookmarks & Alerts: Save specific devices or manufacturers and get notified the moment their regulatory status changes.

Claim a Company: Manufacturers can take control of their profile to add logos, descriptions, and contact info, as well as share eIFUs and a product website link.

Advanced Safety Tracking: Deeper insights into recalls and adverse event trends.

Yes, HaRi search is free to all users with or without an account, and additional usage can be unlocked with an account.

HaRi Pro is for users requiring more usage and functionality including bookmarking, alert notifications and the ability claim a company and upload device information.

We strongly encourage your feedback.

Please use the [contact page] to start the conversation.

HaRi links publicly available adverse event reports (such as FDA MAUDE), recalls, and field safety notices directly to the devices they affect. This allows hospital staff and manufacturers to track the safety profile of a device across its entire global lifecycle. This linkage is not typically provided by regulatory authorities, and is one of the reasons we built HaRi.

From the main search page you can use the filter checkboxes to turn filters on or off for the following categories:

• Manufacturers

• Devices

• Product Codes

• Safety Events
  If you would like to request more filter options please get in touch.

Yes - just type in the three letter product code (e.g. LLZ) into the search bar and HaRi will return all devices within that product code as well as a dedicated page for that code.

GMDN codes, although legally required for all medical devices, are protected by the strict licensing of the GMDN Agency, which has a “No Public Display” clause. Licensees cannot make the GMDN database, or large sets of its codes and definitions, publicly accessible on their own platforms or websites. We believe this is anti-transparent.

Data export features are on the roadmap for Pro subscribers. This will allow you to pull search results and safety event history into CSV or PDF formats for internal hospital reports or regulatory filings.

Your team receives a weekly email digest each Thursday if regulatory changes are found.

• For devices:

  • New authorisations, e.g. an additional 510(k) clearance for a new version of a device, or a new authorisation in a different jurisdiction.

  • Updates to registration details (e.g. address, classification, dates).

  • (coming soon) Safety events, recall alerts

• Manufacturer bookmarks cover all their devices.

This is a common issue. A manufacturer must register their device in each jurisdiction they are placing that device on market. Often this happens over time, through different platforms and done by different people (such as an authorised representative). This can lead to the same device being registered with some variation in the exact names.

Alternatively, the device might have the same name but a different version or intended use across jurisdictions.

HaRi joins devices where the manufacturer name and the device name match. This only joins when we can be confident that devices are an exact match.

Our recommendation to manufacturers is to ensure consistency of their device names across jurisdictions. Our recommendation to regulatory authorities is to collect and display UDI data for all devices, which will enable better cross-referencing.

The regulation 21 CFR 807.92(a)(3) mandates that manufacturers submitting a 510(k) must include “identification of the legally marketed device to which the submitter claims equivalence”. This can either be in a 510(k) summary which is publicly available on the FDA 510(k)database, or a 510(k) statement which is only available on request. For that reason, not all 510(k) statements are publicly available, and so not all device predicates can be traced.

The FDA started digitising public summaries from 2004 onwards. Submissions prior to this are difficult to computationally extract accurate data from since they are scanned copies of physical documents, often with visual artefacts. The FDA introduced the eStar submission format in 2021, with mandatory use from 2023. This digital format includes pre-specified fields for manufacturers to complete, including the named predicate device(s), making it easier to computationally extract the predicate device from the submission documentation. Submissions prior to 2021 were largely written in free text, and so text parsers can sometimes struggle to correctly identify the predicate buried inside the documentation.

PMA and De Novo authorised devices will not have a predicate by definition.

HaRi has advanced data processing to extract predicate information from the summary PDF documents. If you think you have identified missing predicate data for a device on HaRi, please get in touch.

HaRi uses multiple source databases, including, but not limited to:

• US FDA: 510(k), PMA, De Novo, recalls, and MAUDE.

• UK MHRA PARD: UKCA registered devices and manufacturers, FSNs.

• EU EUDAMED: MDR/IVDR device and actor registrations.

• Health Canada: Device and establishment licenses, safety events

• Australia TGA: Australian Register of Therapeutic Goods (ARTG).

• Information Commissioner's Office (UK)

• PubMed

Note: Data from Japan (PMDA), Brazil (ANVISA), and Singapore (HSA) is coming soon.

The TGA database unfortunately does not display device names (consistently) nor UDIs.

For the majority of TGA devices without a name, HaRi uses the device summary for every device from the TGA database and checks for device names within the available summary text against devices known from other sources. If the device name is not in the text, then no linkage can be made.

We encourage manufacturers to use their full device name and UDI in the summary they provide to the TGA. This will enable verifiable device linkage within HaRi. We also encourage the TGA to collect and display device names and UDI data.

Manufacturers of CE marked devices must be registered on EUDAMED. However, not all CE marked devices have been properly registered by the manufacturer, their Authorised Representative or their Notified Body, or there has been a delay. In this case, the device information may not be publicly available on EUDAMED, and so HaRi cannot find or display it.

Some bad actors claim to have a CE mark fraudulently, and they will not appear on EUDAMED. That’s one of the reasons we built HaRi, to raise transparency.

We encourage manufacturers to upload full and complete device information to all relevant EUDAMED modules in timely fashion, which is a legal requirement under the EU MDR.

There are a couple of reasons as to why specific devices may not appear in HaRi:

1) They are not registered, or are incorrectly registered (e.g. under a different brand or company name), in one of the public regulatory jurisdictional databases (e.g. FDA, MHRA, EUDAMED, etc)

2) The device was only registered recently. HaRi scrapes regulatory data weekly, so we advise you to wait 7 days after your registration of a device with a regulatory authority appears in public databases before expecting the device to appear on HaRi.

If you are concerned about a missing or incorrect device on HaRi, please use the [contact page] to reach out.

No. HaRi is designed for regulatory transparency, and we display publicly available information from ground-truth sources. HaRi maintains a historical record, as long as the data is held on the source databases.

Pro users can ‘claim’ multiple companies on HaRi provided they can verify ownership of each one.

In the case of multiple legal entities, companies cannot be merged, since this would distort the fidelity of the ground-source data.

In the case of having the same legal entity listed multiple times in HaRi, please contact us via the “update company” listing page and the HaRi team will be able to merge the listings (and devices) for you.

HaRi can only display information from ground-truth source regulatory databases. If your Intended Use is not on HaRi, that means it is not publicly available on any of our source databases. This can happen for example with older FDA documents, or when manufacturers have not fully registered all of their details on EUDAMED.

To ensure your Intended Use appears on HaRi you should provide the relevant information to one or more of the source databases.

HaRi displays data sourced from regulatory databases, so the easiest way to have more information appear in HaRi is to ensure your medical device registrations are complete and have all required and optional information.

Pro users can ‘claim’ their manufacturer page and associated devices using our verification system. Once verified, manufacturers can upload additional material such as a company logo, company URL, and company description, as well as eIFUs and product website links for individual products.

All uploaded content goes through a review process before being published. Inaccurate or misleading content may be removed without notice.

HaRi uses verified regulatory databases as a ground truth source, and only displays authorised, normalised data. If details about your company or device appear incorrect on HaRi, it likely means they are also incorrect on one or more of HaRi’s source databases. In this case, we would advise you to check each source database and make the appropriate changes there. Regulatory data on HaRi cannot be changed by manufacturers (or the Hardian team), and HaRi cannot write data to any source database.

However, sometimes errors do occur, and if you have checked the source data is correct and believe there is an error in the way HaRi is displaying it, then please use our [contact page]

Publications in HaRi are sourced from PubMed, using a normalised device name and manufacturer name as search string terms. If the device is not named within a publication, it is unlikely to be returned in a PubMed search. Manufacturers are encouraged to use the exact device name, UDI and version numbering in any scientific publications to ensure consistency and transparency.

HaRi runs literature searches based on key terms derived from the company name and/or device name and queries the PubMed API.

If either of these terms are present in a publication, including the abstract, author lists or disclosures, the result will be served. For this reason, company and device names which are less unique can and will return literature search results that do not necessarily relate to the specific device, but do include the key search terms.

We are working on a system where manufacturers on a Pro subscription would be able to curate their literature search results to ensure relevance.

Claiming a company and its associated devices is only available to Pro users.
To make a claim, navigate to the relevant company page and select ‘Claim this manufacturer’. You will then be led through a verification process.

To get started, you will need either: to be logged in with an email address domain which matches one used as part of the regulatory submission process, or, be able to get an email forwarded via someone who was. We do this to ensure an authorised link between the regulatory submissions and the claim to the company on HaRi.