Custom software for an implant register with traceability
Appfront builds software for hospitals and clinics that need to be able to trace implants. In the operating theatre, the UDI of the implant is scanned and linked to the patient and procedure. The data goes to the Dutch National Implant Register (LIR) without manual re-entry. And if a manufacturer issues a recall or safety notice, you can immediately see which patients are affected.
What is software for an implant register with traceability?
The Dutch National Implant Register (LIR, Landelijk Implantaten Register) holds data on certain implants placed in patients. It was set up for traceability: if something is wrong with an implant, the patients who received it must be quick to find. Healthcare providers supply the data, via their EHR or an input portal. In addition, European medical device regulation requires healthcare institutions to store the unique device identifier (UDI) of certain implants. The LIR itself holds no patient data; the link to the patient sits with the healthcare provider.
In practice, stickers from the packaging are stuck onto a form, and someone types the data in later. A lot number is copied incorrectly, or the submission to the register stalls. When a manufacturer issues a safety notice about a particular lot, someone has to search through forms and the EHR to find out which patients are affected, while time is pressing.
We build custom software because registration has to fit your institution: which EHR and surgical planning system you use, which implants you place, how your operating theatres work, and who is responsible for submissions and for actions during a recall. Which implants fall under the register and what the rules require is determined by you together with your quality and safety department; the software records what you need for that.
Scanned, not retyped
The UDI of the implant scanned in the operating theatre, linked to the patient, procedure and surgeon.
Submission to the register
Data sent to the Dutch Implant Register, checked for completeness.
Recall in minutes
See instantly, by product or lot, which patients are affected, with actions per patient.
How we build your software for an implant register with traceability
We start in the operating theatre: which implants, how registration is currently done, which systems are involved, and who supplies.
Your implants, operating theatres, EHR, surgical planning and responsible staff.
Scan the UDI and link it to the patient and procedure, without holding up the procedure.
Submission to the register, and checking for completeness.
Search by product or lot, actions per patient, and then management.
What implant register software with traceability actually does
The components below feature in almost every institution that uses implants. Which ones you need depends on your specialisms.
UDI scanning
Scanning the code on the packaging in the operating theatre.
Linking to the procedure
Implant linked to patient, procedure and surgeon.
Submission
Submission to the register with checks.
Tracing
Search by product, lot or serial number.
Promotions
Actions per patient in the event of a recall or safety notice.
Stock
Implant stock and expiry dates.
Who we build implant register software with traceability for
The software is intended for institutions that implant devices and need to be able to trace them.
Hospitals
Many specialisms and operating theatres. Submission is the core.
Clinics
A few specialisms with many implants. Scanning matters most.
Ophthalmology centres
Lenses in large numbers. Quick registration is what's needed.
Quality departments
Responsible in the event of a recall. Traceability is the core.
Test your idea first: a working prototype in 1 day
With OneDayBuild, we turn your idea into something tangible in one day for €1,150, so you can see whether further development is worth the investment. Decide to go ahead with the full build? Then we credit the full cost.
Explore OneDayBuild →Technology and integrations
This page is about registering and tracing implants. For EHR software, see our page on EHR software; for scanning, our page on a scanner app; and for stock management in healthcare, our page on inventory management for laboratories. You can read about how we work under getting software built.
If you want UDI data from your own system into EUDAMED and onto the label, see our page on a UDI integration.
Why choose Appfront for your implant register software with traceability?
In a recall, every hour spent searching counts. We build around that: scanning instead of retyping, submissions that don't get left behind, and patients who can be found straight away.
No transcription errors
The code comes from the packaging, not a form.
Submissions on time
What still needs submitting is visible.
Fast tracing
Patients for each lot immediately, with actions alongside.
Security and privacy in implant register software with traceability
The software links implants to patients, which is special category personal data. Access is set up by role, data comes from the EHR and is not stored for longer than necessary, and every access is logged. Only the data the register asks for is sent to it.
The software runs in a European data centre or within the institution's environment, with encrypted storage, daily backups and two-factor login.
Frequently asked questions about implant register software with traceability
Questions hospitals and clinics ask before getting started.
It lets staff scan the UDI of an implant in the operating theatre, links it to the patient and procedure, submits the data to the register, checks for completeness, and, in the event of a recall, immediately shows which patients are affected by a product or lot.
The LIR (Landelijk Implantaten Register, the national implant register) holds data on certain implants placed in patients, for traceability. Healthcare providers supply the data, either through the EHR or an input portal. The register itself holds no patient data; linking implants to patients is the responsibility of the healthcare provider.
The Unique Device Identifier is a unique code for medical devices, usually printed as a barcode on the packaging. European regulations require healthcare providers to store the UDI of certain implants.
Check that first. Some EHRs have an implant module that submits to the register, and that may be enough if it works well in the operating theatre. Custom development makes sense when scanning, inventory and traceability currently sit in separate systems.
Immediately. For each product, batch or serial number, you can see which patients received the implant, during which procedure and with which surgeon, along with a list of actions per patient.
No. Scanning takes a few seconds per implant and is done by whoever currently applies the sticker. The rest of the data comes from surgical scheduling and the EHR.
This is set out in the regulations and is sometimes expanded. Which implants apply to you is something you determine with your quality and safety department; the software can register all implants and submit whatever is required.
Want every implant scanned and traceable?
Tell us which implants you place, how registration is handled today and which systems you work with. We'll show you what scanning, submission and traceability look like.