The DPP for Medical Devices

Medical devices are the sector that has already built most of what a digital product passport requires, for reasons that had nothing to do with circularity.

Patient safety and post-market surveillance drove the creation of a unique identifier scheme, a central registry and a comprehensive technical file. The infrastructure exists. What is missing is the environmental half of the record.

UDI already solved identity

Unique Device Identification assigns a device identifier for the model and a production identifier covering lot, serial number and expiry. Together they identify a specific unit, and the scheme is built on GS1 and other accredited issuing agencies.

That is a substantial head start. It also means the sector should resist inventing a second identifier for passport purposes, which would fragment exactly the thing UDI unified.

EUDAMED is a working registry

The European database on medical devices holds registration, certificate, clinical investigation, vigilance and market surveillance data, structured and centrally accessible.

The pattern is clear. Everything a regulator needs to protect patients is there; nothing an environmental assessment would need is. The two halves were built by different communities for different reasons and have never been joined.

Single-use designation is the contested question

Healthcare generates a large volume of waste from devices designated single use, many of which are technically capable of being reprocessed and reused safely.

Regulation (EU) 2017/745 permits reprocessing of single-use devices only where a member state allows it and under conditions treating the reprocessor as a manufacturer, with full responsibility for the reprocessed device. Member states differ, so the same device may be reprocessable in one country and not in another.

• The reprocessor becomes the manufacturer, assuming conformity and liability obligations in full.
• Validation must demonstrate that cleaning, sterilisation and function meet original performance.
• Cycle limits matter — materials degrade under repeated sterilisation, so counting cycles is essential.
• Traceability to patient level is required, which UDI supports and paper systems do not.

The third point is where a passport genuinely helps. Reprocessing depends on knowing how many cycles a specific unit has undergone, and that is a per-unit history rather than a product attribute.

Why environmental data is genuinely absent

It is worth being fair about why. Medical device regulation is built around patient safety, and environmental performance has never been a conformity criterion.

A manufacturer that reduced a device’s footprint received no regulatory credit and one that increased it faced no penalty. There was no mechanism through which environmental data could affect anything, so it was not collected.

Public procurement is the route with the most immediate commercial force. Health systems are large buyers with sustainability commitments, and a tender weighting product footprint creates demand for data no regulation requires.

What a device passport should add

The sensible design extends the UDI record rather than creating a parallel one, and adds only what is genuinely missing.

Material composition at a level supporting waste segregation, product carbon footprint with a stated boundary, packaging composition for the sterile barrier system, reprocessing status and cycle count where applicable, and end-of-life handling instructions that distinguish clinical waste from recoverable material.

Par où commencer

Begin with packaging and with the high-volume disposables, because that is where both the waste volume and the achievable change concentrate.

A sterile barrier system is packaging in the ordinary regulatory sense and falls under Regulation (EU) 2025/40 alongside everything else. Recording its composition per component is work the sector has to do regardless, and unlike device reprocessing it requires no change to clinical practice or member state law.

The second move is to record material composition at the granularity that waste segregation actually uses. Clinical settings separate waste into streams defined by infection risk and by sharps handling rather than by polymer, so a composition record that ignores how the device will be discarded describes the wrong thing.

Getting that right requires talking to the clinical waste teams who handle the device rather than to the engineers who designed it. They are not usually consulted on product data, and they know things about how a device is disposed of that no internal system records anywhere.