The EU Medical Device Regulation (Regulation (EU) 2017/745, or MDR) sets out exactly what has to appear on a device’s label and packaging before it can carry a CE mark and go on sale in the European Union. The rules live mainly in Annex I, Chapter III (Section 23), and getting them wrong is one of the most common reasons notified bodies send technical documentation back for corrections.
This guide walks through what belongs on the label itself, how the Unique Device Identifier (UDI) and safety symbols fit in, and the mistakes that trip up packaging teams most often — whether you’re designing a label from scratch or auditing an existing one before a recertification audit.
Quick Answer
Under EU MDR Annex I, Section 23.2, a medical device label must include the device and manufacturer’s identity, a lot/serial number, the UDI carrier, intended purpose (where not obvious), sterility and expiry information where relevant, any required warnings, and the CE mark with notified body number for higher-risk classes. Instructions for use (IFU) cover the rest of the required information and can only be omitted for a narrow set of low-risk Class I and IIa devices.
What Must Appear on the Label
Start with identity: the device’s name or trade name, plus enough detail for a user to identify the exact device and package contents (model, size, configuration, etc.). If the intended purpose isn’t obvious from the device itself, state it on the label too.
Next comes accountability. The label needs the manufacturer’s name (or registered trade name/trademark) and the address of its registered place of business. If the manufacturer is based outside the EU, the label must also show the name and address of the EU Authorised Representative. When an importer or distributor repackages or relabels the product, their details get added as well, without covering the original manufacturer’s information.
Traceability elements are non-negotiable: a batch code or serial number (preceded by “LOT” or an equivalent marking), and the UDI carrier in both machine-readable (barcode/RFID) and human-readable form. Add the manufacture date or expiry date as applicable, and for devices with a defined shelf life, the “use by” date in year-month format.
Where relevant, the label must also flag: sterile status and sterilization method; single-use status; custom-made device status; whether the device is for clinical investigation only; the presence of a medicinal substance or human/animal tissue derivatives; and any CMR (carcinogenic, mutagenic, or reprotoxic) substance present above 0.01% weight by weight. Finally, higher-risk device classes require the CE mark accompanied by the four-digit identification number of the notified body that carried out the conformity assessment.
UDI Placement and Symbols
The full UDI (UDI-DI plus the applicable UDI-PI, such as lot number or expiry date) must appear on the device label and on every higher level of packaging, not just the shelf pack. A common misconception is that the Basic UDI-DI needs to be printed on the package — it doesn’t. The Basic UDI-DI is a separate regulatory identifier used in technical documentation, the Declaration of Conformity, the CE certificate, and the EUDAMED registration, not on the packaging itself.
If a label is genuinely too small to fit both the machine-readable (AIDC) and human-readable (HRI) parts of the UDI, the space-constrained provisions in Annex VI, Part C let you move the AIDC or HRI to the next higher packaging level instead.
For symbols — sterility, single use, manufacturer, expiry date, and similar — use ISO 15223-1:2021, which the European Commission harmonized under the MDR in January 2022. Using the current symbol set means you don’t have to spell out each symbol’s meaning separately in the accompanying information, but using an outdated symbol edition is a frequent finding in notified body reviews.
Sterile packaging has its own rule under Section 23.3: the sterile barrier system itself must indicate the sterile state and sterilization method, and it must be identifiable as the sterile packaging distinct from any outer shipping carton. Devices with electronic instructions for use (eIFU), permitted for certain professional-use and implantable devices under Commission Implementing Regulation (EU) 2021/2226 — which took effect in January 2022 and replaced the older Regulation (EU) No 207/2012 issued under the previous Medical Devices Directive regime — still need the paper label to carry a web address or other means of accessing the IFU, plus the underlying label content above.
Tips / Common Mistakes
Don’t print the Basic UDI-DI on packaging out of caution — it’s not required there and can create confusion with the actual UDI carrier. Keep it in the technical file and EUDAMED record instead.
Check each destination country’s language rules separately. MDR Article 10(11) lets individual EU member states set their own language requirements for labels and IFUs, so a label compliant for Germany may need a translated variant for other markets.
Confirm you’re using ISO 15223-1:2021 symbols, not the older 2016 edition — several symbols and their meanings changed, and notified bodies check this during audits.
Treat the IFU-omission allowance as narrow, not default. It only applies to specific Class I and IIa devices that can be used safely without instructions, and manufacturers still need a documented risk-based justification.
When distributors or importers relabel or repackage a device, they must add their own identifying details without obscuring or altering the manufacturer’s original label information — plan physical label layout with that extra space in mind from the start.
Explore more: More EU MDR and packaging compliance guides.
EU MDR packaging labeling FAQs
Does the Basic UDI-DI need to be printed on the packaging?
No. The Basic UDI-DI is a regulatory identifier used in technical documentation, the Declaration of Conformity, and EUDAMED. Only the full UDI (UDI-DI plus UDI-PI) goes on the label and packaging.
Can instructions for use be left out of the package?
Only for certain Class I and IIa devices that MDR allows to be used safely without an IFU, based on a documented risk justification. Most devices still require a full IFU, whether printed or, for eligible professional-use and implantable device categories, provided electronically under Commission Implementing Regulation (EU) 2021/2226.
What symbol standard should packaging labels follow?
ISO 15223-1:2021, which was harmonized under the MDR in January 2022. Using this edition means the symbols’ meanings don’t need to be separately explained in the accompanying information.
Where does the CE mark and notified body number need to appear?
On the label or packaging, visible and legible, for any device class that required notified body involvement in conformity assessment. Class I devices assessed solely by the manufacturer show the CE mark without a notified body number.
Do labels need to be translated for every EU country?
Each member state can set its own language requirements for labels and IFUs under MDR Article 10(11), so requirements vary by country — check the specific destination market rather than assuming one language covers the whole EU.
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