EDUCATION: Labelling & the Digital Product Passport - a checklist
The EU's Digital Product Passport (DPP) is arriving in stages.
Batteries are up first from February 2027 under the Battery Regulation, with textiles, electronics, furniture, and other product categories following through 2027-2029 under the Ecodesign for Sustainable Products Regulation (ESPR). For Medical Devices, the DPP is the same discipline that UDI already demands, extended to cover the additional identifiers arriving alongside it. So here’s how to get ahead….
We have lots of information links to share in this article so they are here, before we get into the details, as an easy reference point.
Digital Product Passport (DPP)
Ecodesign for Sustainable Products Regulation (ESPR)
Unique Device Identification (UDI)
Medical Device Regulation (MDR)
The manufacturers who are best positioned for the Digital Product Passport won't be the ones who wait to take action just before it is required - they'll be the ones who already treat every code on every label as something that has to be verified, have the processes and system in place now managing verification and know they have the capabilities available to meet the new regulations from day one.
Medical devices aren't in the first wave of the DPP. In fact, the EU has signalled it may exempt product categories where an equivalent digital information system already exists. And for medical devices, one already does: UDI (Unique Device Identification) is mandatory under the Medical Device Regulation and In Vitro Diagnostic Regulation since 2021, backed by the EUDAMED database.
So, as a manufacturer of medical devices, the most useful way to think about the DPP is not as a brand new obligation where you need to build process from scratch to meet it, but as a related, converging requirement. For most manufacturers, that means it will eventually sit alongside - and in some cases plug into – processes and systems you've already implemented.
For your label production team, the question isn't whether your labelling room can produce machine-readable, database-linked product identity; it’s actually whether each label is accurate enough to trust.
You've already built a Digital Product Passport - it's called UDI
Under MDR/IVDR, every device must carry:
UDI-DI (Device Identifier) - a fixed code identifying the device model, encoded in a GS1, HIBC, or ICCBBA-compliant barcode or 2D DataMatrix
UDI-PI (Production Identifier) - variable data such as lot number, serial number, or expiry data
Human-readable interpretation of both - printed alongside the code
A registration in EUDAMED - linking that identifier to structured device data
That's a data carrier, a unique identifier and a linked digital record - the three defining features of a Digital Product Passport, years ahead of the ESPR schedule.
The DPP's data model is broader (material composition, carbon footprint, repairability, end-of-life handling), but the mechanism - a scannable code on the product, resolving to a trustworthy digital record - is one which medical device manufacturers already operate at scale.
Where it gets harder: batteries, electronics, and packaging
The exemption for medical devices isn't absolute though. Manufacturers should expect DPP obligations to reach them indirectly through:
Battery-powered devices - infusion pumps, patient monitors, portable diagnostic equipment and other battery-containing devices fall under the Battery Regulation's passport requirements regardless of the exemption on the device itself
Electronic sub-assemblies - as DPP rules extend to electronics, components sourced from third-party suppliers may need to carry their own passport data, which manufacturers will need to reconcile with device-level UDI record
Secondary packaging - cartons, trays, and shipping units aren't covered by UDI in the same way the device label is but may fall within scope as ESPR rules extend to packaging materials.
In practice, that means a single medical device – eg a connected infusion pump - could end up carrying two parallel, overlapping identity systems: UDI on the device label, and a DPP data carrier on its battery. Both need to scan correctly, resolve to the correct record and never get mixed up with another unit on the line.
It’s label print and inspection problem before it's a data problem
Manufacturers tend to treat UDI and DPP as software and database projects: get the product master data right; get it into EUDAMED or the DPP registry; done. But a passport is only trustworthy if the physical code printed on the product label matches what's in the database, prints clearly enough to scan on the first attempt and never duplicates another unit's identity.
That's where Perceptor IoT - as an end point label inspection and verification solution - becomes invaluable as it does the real work without error prone manual intervention:
Barcode and DataMatrix grading - to ISO/IEC standards, not just a pass/fail scan; a code that scans in a clean test environment can still fail a wall-mounted scanner in a hospital storeroom
OCR/OCV matching - between the encoded UDI-DI/PI and the human-readable text to catch print drift or mismatched variable data before it leaves the line
Real-time, cross-site duplicate checking - critical when a single UDI-DI is produced across multiple facilities and so the risk is that two devices could carry the same identifier; this is exactly the kind of error that undermines trust in the whole passport system
Full audit trail - what was inspected, when, by which print station and operator; you need the same record-keeping attention to detail that regulatory inspectors already expect for UDI compliance. The DPP's lifecycle traceability requirements will extend further, recording maintenance, calibration and service events against the product's digital identity over its working life.
A real life example
A manufacturer produces a battery-powered patient monitor for the EU market:
The device label carries a GS1 DataMatrix encoding the UDI-DI and lot-specific UDI-PI, inspected and verified as it was printed for grade, contrast and OCR/OCV match against the source data.
The device's battery, sourced from a third-party supplier, arrives pre-labelled with its own Battery Passport data carrier; the manufacturer's inspection process confirms it's present, undamaged and scans correctly before final assembly, rather than assuming the supplier got it right.
Both identifiers, along with the inspection results themselves, are logged and tied to the batch record so if either passport is later queried by a distributor, a hospital, or a regulator, the manufacturer can demonstrate not just that the data was correct, but that it was verified.
None of this requires waiting for medical devices to be formally brought into DPP scope. It's the same discipline UDI already demands, extended to cover the additional identifiers arriving alongside it.
A checklist to get ahead of DPP
For medical device manufacturers, DPP readiness isn't a separate project from UDI compliance - it's an extension of it. A few practical steps:
Audit - does your current label inspection process grades codes to a recognised standard or simply confirms a scan succeeds?
Battery power - identify which of your devices are battery-powered or contain electronic sub-assemblies likely to fall under DPP ahead of the device itself.
Multiple identifiers - check whether your inspection and data logging can handle multiple identifiers per product - UDI and DPP data carriers, potentially from different standards bodies - without manual reconciliation.
Duplicate check - is your duplicate label checking global and real-time, not just local to a single line or shift? Even more important where production of a product spans multiple sites.
Perceptor IoT provides secure, real-time label inspection and verification for manufacturers in regulated industries, including medical device production. Get in touch with the team here to talk through UDI and DPP readiness for your product and package labelling.