Methodology

deviCERTS is a catalogue built from public medical device registries. It shows each device with the authorizations and identifiers the registries hold for it, and says where each statement comes from.

It is not an official register and it does not give regulatory or legal advice. The record in the registry itself prevails. Registry data can be incomplete or out of date, and so can our copy of it. Check the original record before you rely on it.

The monthly runs are scheduled for the first Saturday and the first Sunday of each month (UTC), a few hours apart. In January, April, July and October the runs that read a full file are the quarterly full reconcile. The other months read only what changed, or for EUDAMED devices, walk the whole registry again.

A run that fails is attempted up to three times in all, six hours apart. If it still fails it waits for the next slot. A run that is more than 40 days overdue starts as soon as the system is up.

These are schedules, not guarantees. A change made by a registry can take a month to appear here, and a change to an existing FDA record that does not alter the registry’s counts can wait for the next quarterly full file. The line “Source …, synced <date>” on a device page gives the latest date on which we retrieved any of the records behind that page.

A record that is missing from two complete full listings of its registry in a row is shown as no longer listed. The page stays online, with a notice. A device that is withdrawn, expired, cancelled or suspended carries no model-written text.

One physical device can have a record in several registries, and several records in one registry. We merge records into one device page only on evidence, in this order:

• A shared Primary DI. The same Primary UDI-DI in two records means the same device.
• Manufacturer and catalogue number across GUDID and EUDAMED. The US and EU systems give the same product different identifiers, so a GUDID record and a EUDAMED record that have the same manufacturer and the same catalogue (reference) number can be merged. We do this only when exactly one group on each side shares the key, and refuse it when the result would be large, would hold more than one catalogue number on either side, would join different manufacturers, or would join manufacturers in different countries.
• A similar name, only together with the same catalogue number. A name that looks alike is not enough, because unrelated devices share house-brand names. The record must also carry the same catalogue number as the candidate, and the group may not grow past 50 members.

What we do not merge:

• Records that only share a 510(k) or PMA number. One clearance often covers a whole product family, so the number is kept as a link between records and shown on the page, not as identity.
• Records that only share a name, or only a Basic UDI-DI (which identifies a device model, not a single product).
• Two EUDAMED records with different Basic UDI-DIs and different Primary DIs, on the strength of a shared name and catalogue number. A legacy (MDD) record and its MDR re-registration share a Primary DI and can still be one page.

A merged record keeps its old address: the old page redirects to the merged one. When in doubt the system keeps two pages, because a missed merge shows two pages while a wrong merge hides one. Both kinds of error happen. If you find one, write to contact@devicerts.com.

Counts overlap. Because one device can be in several registries, the number of devices per registry adds up to more than the number of device pages. We never add them up.

Manufacturer records are matched on the company name with legal endings such as Inc, LLC, Ltd or GmbH removed, within one country. An entity-resolution service may also point a record at an existing manufacturer when it scores 0.95 or higher. Names that are similar but below that go to a review queue and are not merged automatically. FDA establishments are identified by their FEI number.

An FDA applicant is not always the manufacturer. Where the two differ the page shows both.

A recall is shown on a device page when the recall names a 510(k), PMA or De Novo number that the device also holds. It is marked as naming the device or its product code when the record says so, and otherwise as sharing only the clearance. A recall that names no submission number can usually not be tied to a device and then appears on the manufacturer page only. The recalling firm is tied to a manufacturer by its name, so a recall can be missing or misplaced where names differ. “None found” means none in the data we hold, not that none exists.

Verified by deviCERTS is a badge that a deviCERTS reviewer sets on a device after reviewing a validation request for it. It is not a regulatory approval and it does not replace the registry.

A page without the badge is marked Unverified: registry data that deviCERTS has not checked. Most pages are unverified. Everything on them comes from the registries listed above, apart from the model-written text described next.

Some pages carry text written by a language model from registry facts: the page title and description, an overview, answers to common questions, a company summary or a category summary. The overview, the answers, the company summary and the category summary carry a label on the page, such as “AI-generated … Not verified by deviCERTS or the manufacturer”. Some answers and recall summaries are not written by a model but assembled from registry fields by fixed templates; they are labelled “Generated automatically from registry data”. The title and description sit in the page head and carry no label. Not every page has such text, and such text is not shown for devices that are withdrawn, expired, cancelled or suspended.

Before a text is stored, rules reject it automatically. They check length and form, and refuse claims that the record does not support, such as sterility, single use, or the words clearance and approval where the record holds no such authorization, and text that presents an inactive authorization as current. Company summaries are also checked for evaluative wording. The rules reduce errors. They do not prove a text correct. Text written before the current rules may contain statements that the registry data does not support. Treat every model-written statement as unconfirmed and use the registry record.

A person does not review model-written text unless the page says so. To report an error, write to contact@devicerts.com and name the page. We reply within 5 working days.

To report a wrong statement, a wrong merge or a missing record, write to contact@devicerts.com with the page address and what is wrong. To tell us about a device that is not in the catalogue, use the suggestion form. We add a device when we can match it to a registry record. If the registry itself is wrong, the fix has to be made in the registry.

deviCERTS is run by DIGITALY in Warsaw. DIGITALY is responsible for this page and for the content of the site. Contact: contact@devicerts.com. See also About deviCERTS.