Frequently asked questions
Can labels from this tool be used directly on products?
No. The tool creates label drafts with a DEMO watermark so you can check whether all mandatory markings are present. Final labels must be controlled in the manufacturer's own QMS and match the technical documentation and IFU. On request we review your final labels professionally.
Which regulations and standards are covered?
EU MDR/IVDR, UK MDR 2002 and US FDA labeling requirements (21 CFR 801/809/830); symbols follow ISO 15223-1:2021 and its 2025 amendment. You can select several markets at once – the tool combines the mandatory markings and shows the legal basis for each.
Which UDI barcodes are supported?
GS1 (DataMatrix and GS1-128) and HIBCC. The tool generates barcodes containing the device identifier (DI) and production identifiers (PI: lot, serial number, manufacturing and expiry date). The UDI-DI itself must be obtained from an issuing agency such as GS1; the tool does not assign it.
Why do I log in with my e-mail, and how often can I use it?
You log in with a code sent to your e-mail – no password needed. Each e-mail address can export 3 labels free of charge; exporting the same label in another format counts once. When they are used up, leave us a message on the page and we will contact you.
Is the label content I enter stored?
Drafts you do not export stay only in your browser. Each exported label is archived on EVERBIZ servers to answer your requests and improve the tool; accounts with no activity for 24 months are deleted automatically. See the privacy policy for details.