Scope

ESPR and medical devices — what actually applies today

If you make or import medical devices and someone has told you the EU digital product passport is coming for you next year, the honest position is more boring and more useful than that. Medical devices are not in the first ESPR working plan, so there is no dated passport obligation for the device itself. There is, however, a dated obligation that catches a great many medical devices anyway — and it is not the one people are selling.

Last updated: 28 August 2026

In one line: no ESPR delegated act covers medical devices, so the device has no dated DPP deadline. But if it contains an industrial battery above 2 kWh or an LMT battery, the battery passport applies from 18 February 2027 — and that one is already law.

What the working plan actually says

The ESPR — Regulation (EU) 2024/1781 — has been in force since July 2024, but it does not by itself require a passport for any product. It is a framework: obligations arrive per product group through delegated acts, and until a delegated act exists for your group, nothing is dated.

The first ESPR working plan, adopted in April 2025, names its priority groups explicitly. As final products: textiles (apparel), furniture including mattresses, and tyres. As intermediates: iron and steel and aluminium. It also covers horizontal requirements such as repairability and recyclability that can cut across groups.

Medical devices are not on that list. No delegated act covers them, so there is no ESPR passport deadline for a medical device today. Anyone quoting you a date for medical devices under ESPR is quoting a date that does not exist.

Two honest qualifications. ESPR is deliberately broad in what it can reach, so "not in the first working plan" is not "never" — later working plans are expected from around 2028. And company obligations typically bite about 18 months after a delegated act enters into force, so even a future listing would come with a long runway rather than a surprise.

The obligation that does catch medical devices

Here is the part that matters, and it has nothing to do with ESPR.

The Batteries Regulation, (EU) 2023/1542, is a separate law with its own hard date. From 18 February 2027 a battery passport is mandatory for EV batteries, LMT batteries and industrial batteries above 2 kWh — and under Article 1 the Regulation applies to batteries incorporated into products. Placing a finished device on the EU market means placing the battery inside it on the market too.

For medical devices that is not a hypothetical. Mobile imaging units, powered hospital beds and patient-transfer equipment, surgical robots, autonomous disinfection and logistics robots, mobile ventilators and dialysis units, and larger battery-backed equipment carts can all clear 2 kWh. Powered mobility equipment raises the LMT question separately, where no capacity threshold applies at all.

Conversely, most handheld and bedside devices run on portable batteries, and portable batteries are outside the passport obligation — they carry labelling, collection and removability duties, but not Article 77. So the question is specific, not general: does any product in our range carry a pack above 2 kWh?

How this sits alongside the MDR

Medical devices already live under the Medical Device Regulation, (EU) 2017/745, with its own technical documentation, UDI system and post-market surveillance. Two points are worth being clear about, because they are frequently conflated.

A UDI is not a product passport. Both are identifiers attached to a device and registered in an EU database, which is why they get confused. But UDI identifies the device for traceability and vigilance; a passport is a structured sustainability and circularity record with tiered access, reached through a data carrier on the product. Being in EUDAMED does not discharge a battery passport obligation.

MDR compliance does not exempt the battery. The Batteries Regulation applies to the battery as a product in its own right, regardless of what regime governs the device around it. In practice the two teams are usually different people, which is how this gets missed: regulatory affairs is watching MDR, and nobody is watching the cell.

What to actually do, in order

Do not start an ESPR project. There is no delegated act and no date for medical devices. Spending budget against an invented deadline is the most common mistake in this space right now.
Inventory your batteries instead. For each product line, ask whether it contains a pack above 2 kWh, or one that drives a wheeled vehicle. That list — not your device catalogue — is your actual obligation.
If anything is in scope, treat February 2027 as real. The binding constraint is not software but supplier data: carbon footprint, recycled content per metal and due-diligence evidence come from your cell supplier and take weeks to months to obtain.
Keep a watching brief on ESPR. A later working plan could add device categories, and horizontal requirements on repairability could touch electronics sooner. Neither is a reason to buy anything today.

If you want the battery answer quickly, the free readiness check maps a catalogue against the obligation in a couple of minutes, and the complete field list is published free as a page, JSON and CSV under CC BY 4.0 — no sign-up, so you can check your own documents without talking to anyone.

Frequently asked questions

Are medical devices covered by the ESPR?

Not in the first working plan. The April 2025 plan names textiles, furniture including mattresses, tyres, iron and steel, and aluminium. No delegated act covers medical devices, so there is no dated ESPR passport obligation for a medical device today. ESPR is broad enough to reach them in a later working plan, expected from around 2028, but that is not a deadline.

Does my medical device need a digital product passport?

The device itself, not under ESPR today. But if it contains an industrial battery above 2 kWh or an LMT battery, that battery needs a passport from 18 February 2027 under Regulation (EU) 2023/1542, which applies to batteries incorporated into products. Portable batteries in handheld and bedside devices are outside the passport obligation.

Does a UDI count as a digital product passport?

No. A UDI identifies a device for traceability and vigilance under the MDR and is registered in EUDAMED. A product passport is a structured sustainability and circularity record with tiered access, reached through a data carrier on the product. Being registered in EUDAMED does not discharge a battery passport obligation.

We comply with the MDR — is the battery covered by that?

No. The Batteries Regulation applies to the battery as a product in its own right, whatever regime governs the device around it. This is a common gap because regulatory affairs teams watch the MDR while nobody is assigned to the cell inside the product.

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