EchoFill › Use cases › Medical device registration

Typing device records into EUDAMED or GUDID by hand?

For regulatory affairs and quality staff at small medical device manufacturers. The batch tools described here arrive with EchoFill Business in the next update. We haven't tested EUDAMED or GUDID yet, and we're looking for 3 regulatory teams to try it with us.

EU device registration in EUDAMED stopped being optional this year. According to this summary from Sqanit, use of the UDI/Device registration module became mandatory on 28 May 2026, and devices already on the market (legacy devices) are due by 28 November 2026. In the US, device identifiers go into the FDA's GUDID. Both accept records through a web interface, one device at a time.

For a company with a large portfolio, that web interface isn't the right route. For a small team with a manageable number of devices, it often is, and it means typing the same manufacturer details, the same classification answers and a long list of device attributes into form after form.

First: large portfolios should use the bulk routes

Both systems offer routes built for volume. EUDAMED accepts XML bulk uploads and machine-to-machine (M2M) data exchange; the European Commission's EUDAMED help on modes of data input explains them. GUDID accepts structured submissions alongside its web interface. If you have hundreds of device records, a product data system or a UDI service provider, use those. EchoFill is not a substitute for them.

EchoFill is for teams that enter a manageable number of records through the web forms themselves, and want fewer retyped fields and fewer typos while they do it.

Where EchoFill could help

• Repeated answers. Record a device form once. Next time, the answers that are the same for every device (manufacturer details, authorised representative, common classification answers) fill in one click. This part works today on standard web forms.
• Batch fill from your device list. In the next update, Business turns a recorded form into a CSV template. Paste your device list from your spreadsheet, one device per row, import it, and fill each record with one click. You review and submit each one.
• Copy between systems. Also in the next update: copy the answers from a web form in one system and paste them into matching fields in another, matched by label and by meaning.

How a test would work

1. Enter one device by hand in the portal, the normal way, and click EchoFill → Record this form.
2. Download the CSV template, add a few devices from your spreadsheet, and import it.
3. Open a new device record, fill row 1, and check every field against your source data before you save.
4. Tell us which fields filled correctly and which didn't. We fix what we can.

EchoFill never clicks Save or Submit. A person checks every record before it goes in, which is what you'd want for regulatory data anyway.

What we haven't tested

EchoFill has not been tested on EUDAMED or on the GUDID web interface. Both need an account and a login, which we don't have. We are looking for 3 regulatory teams to try it on their own records with us, as design partners: Business free for six months in exchange for 30 minutes of feedback a month. Until then, treat any claim that a form filler "works with EUDAMED" with caution, including ours.

Long multi-step registration forms, conditional sections and search-as-you-type fields are exactly where form fillers struggle. EchoFill handles custom dropdowns, multi-step forms and modern web apps in general, but we won't know how it behaves on these portals until it's been tried.

Your quality system and your data

Software used in regulated processes often has to be assessed under your quality system; ISO 13485:2016, for example, asks manufacturers to validate the application of computer software used in the quality management system. Whether a browser form filler is in scope, and how much assessment it needs, is your QA team's decision. We'll give you what you need for that assessment: what EchoFill stores, where, and what it never does.

EchoFill keeps recorded forms and imported spreadsheets in the browser on the user's computer, in Chrome's local extension storage. There is no EchoFill server, no account and no AI service involved, so device data isn't uploaded anywhere new. The privacy policy has the full detail.

Common questions