---
title: MDR Labeling Requirements: What Must Appear on Your Device Label
description: MDR Annex I Chapter III Section 23 lists what must appear on a medical device label. Here is the complete list with how it applies to small labels.
authors: Tibor Zechmeister, Felix Lenhard
category: Technical Documentation & Labeling
primary_keyword: MDR labeling requirements
canonical_url: https://zechmeister-solutions.com/en/blog/mdr-labeling-requirements
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# MDR Labeling Requirements: What Must Appear on Your Device Label

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **MDR labeling requirements are set out in Annex I Chapter III Section 23.2 of Regulation (EU) 2017/745. Every medical device label must carry a defined list of particulars: the device name, the manufacturer's name and registered place of business, details needed to identify the device and its contents, the UDI carrier where applicable, the expiry date or lot or serial number, special storage or handling conditions, any warnings or precautions, the intended purpose where not obvious to the user, and the indication "medical device." The CE marking is governed separately by Article 20. Language is governed by Article 10(11). Symbols, where used in place of words, must come from a recognised standard — in practice EN ISO 15223-1:2021. Small labels do not exempt a device from any of this; they force the manufacturer to plan the label hierarchy so every required element lands somewhere the user can find it.**

**By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.**

---

## TL;DR

- Annex I Chapter III Section 23.2 of Regulation (EU) 2017/745 is the legal anchor for every medical device label. Every element on a compliant label maps to a subparagraph of Section 23.2 or to a linked article.
- The CE marking is governed by MDR Article 20 and must be affixed visibly, legibly, and indelibly to the device or its packaging, and also appear in the instructions for use and on sales packaging. Where a notified body was involved, the CE mark is followed by that body's four-digit identification number.
- Language is set by MDR Article 10(11): the information supplied with the device must be in one or more official Union languages determined by the Member State where the device is made available.
- The UDI carrier must appear on the label under MDR Article 27 once the UDI obligation applies to the device class.
- Where symbols replace words, the standard referenced in practice is EN ISO 15223-1:2021 — symbols for use with medical device labels, labelling, and information supplied.
- Small labels do not grant exemptions. They force structured use of immediate label, sales packaging, and IFU so every required element appears at least once in the information supplied with the device.

---

## Why the label is the audit's first stop

The label is the first thing a notified body auditor picks up. It sits at the intersection of the technical documentation, the risk management file, the clinical evaluation, and the marketing material. A clean label is evidence that the rest of the file is in order. A messy label is a signal to open every other drawer in the cabinet. We have seen auditors reach for the Section 23.2 checklist before they reach for anything else, and for good reason — if the label is wrong, nothing downstream can be right.

Founders underestimate this. The label gets handed to the graphic designer late in the project, the designer builds it from the brand layout, and regulatory elements are retrofitted. What should come out of the file ends up bolted onto the brand. The fix is to treat the label as a regulated deliverable from the first design sprint — derived from Annex I Chapter III Section 23 the same way the risk file is derived from EN ISO 14971:2019 and the QMS is derived from EN ISO 13485:2016+A11:2021.

This post walks through exactly what Section 23.2 requires, how the CE mark and UDI sit on top of it, what language coverage is legally required, how to use ISO 15223-1 symbols, and how to handle labels that are physically too small to carry everything directly.

## What Annex I Chapter III Section 23.2 requires

Section 23.2 of Annex I lists the particulars that must appear on the label of every medical device. The list is specified in Regulation (EU) 2017/745, Annex I, Chapter III, Section 23.2. Reduced to plain language, the label must carry, where applicable to the device:

- The device name or trade name.
- The details strictly necessary for the user to identify the device, the contents of the packaging, and, where not obvious to the user, the intended purpose of the device.
- The name, registered trade name or registered trade mark, and address of the registered place of business of the manufacturer. For manufacturers established outside the Union, the name and address of the authorised representative.
- Where applicable, an indication that the device contains or incorporates a medicinal substance, human blood or plasma derivative, tissues or cells of human or animal origin, or their derivatives.
- Where applicable, information labelled in accordance with the provisions on devices containing substances classified as carcinogenic, mutagenic, toxic to reproduction, or endocrine disruptors as referenced in Annex I.
- The lot or batch code (preceded by the word "LOT") or the serial number of the device.
- Where applicable, an unambiguous indication of the date until which the device may be used safely, expressed at least as the year and month.
- Where no indication of the date until which it may be used safely is given, the date of manufacture. This may be included as part of the lot or serial number, provided the date is clearly identifiable.
- An indication of any special storage or handling condition that applies.
- If the device is supplied sterile, an indication of its sterile state and the sterilisation method.
- Warnings or precautions that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum on the label itself, in which case more detailed information must appear in the instructions for use, taking into account the intended users.
- If the device is intended for single use, an indication of that fact. A manufacturer's indication of single use must be consistent across the Union.
- If the device is custom-made, the words "custom-made device".
- An indication that the device is a medical device. If the device is intended for clinical investigation only, the words "exclusively for clinical investigation" must appear.
- The UDI carrier, as referenced in MDR Article 27 and Annex VI Part C.

Every single one of the above traces verbatim to a subparagraph of Section 23.2. Reference the exact subparagraphs in Regulation (EU) 2017/745, Annex I, Chapter III, Section 23.2 when building the label — do not work from summaries, work from the regulation text.

## The minimum label content set

The minimum content set is whatever Section 23.2 marks as mandatory for your specific device. There is no universal "lite" list. The applicability of each element is determined by the device's characteristics: a non-sterile non-implantable Class I device does not need the sterility indication or the implant card cross-reference; a device without an expiry does not need the expiry date but still needs the manufacture date or a lot code that encodes it; a device without a medicinal substance does not need that disclosure.

What never goes away, for any device under the MDR:

- Manufacturer name and registered place of business.
- Device identification (name and the details necessary to identify the contents).
- Lot or serial number.
- The indication that the product is a medical device.
- The CE marking under Article 20 (with the four-digit notified body number where the conformity assessment required notified body involvement).
- The UDI carrier under Article 27 (once the UDI obligation applies to that device class — the obligation phases in by class and by date).
- Any warnings or precautions that have to reach the user at point of use.

These are the anchors. Everything else on Section 23.2's list is applicability-driven.

## How to cope with small labels

Small devices — implants, micro-components, single-use disposables with tiny primary packaging — cannot physically carry every Section 23.2 item on the immediate label. Section 23.2 and Section 23.1 anticipate this by allowing information to be distributed across the label on the device, the label on the sales packaging, and the instructions for use. The MDR does not exempt small devices from any required element; it requires the information to be supplied with the device as a whole, across the layers of packaging.

The practical hierarchy looks like this. The immediate device label carries the items that have to stay with the device itself through its entire use — at minimum, the manufacturer identification, device identification, lot or serial number, UDI carrier, the CE mark, and any warning or symbol the user needs to see in the moment of use. The sales packaging carries everything else from Section 23.2 that does not fit on the immediate label: storage conditions, expiry, "medical device" indication, sterile state, single-use indication, full manufacturer address. The IFU carries the detailed warnings, contraindications, and every element that does not need to be on either label layer.

The rule is that every required Section 23.2 element appears somewhere in the information supplied with the device, and the user can follow a continuous chain from the device to the information without getting lost. Symbols from EN ISO 15223-1:2021 carry much of this compression load — a single symbol can replace a sentence of text — which is why symbol discipline matters more the smaller the label gets.

## Symbol usage under EN ISO 15223-1:2021

Annex I Section 23.1(h) allows information to be supplied by means of internationally recognised symbols, and requires any symbol or identification colour used to conform to harmonised standards or common specifications; where no harmonised standard or common specification exists, the symbols and colours must be described in the documentation supplied with the device. (Regulation (EU) 2017/745, Annex I, Chapter III, Section 23.1.)

The recognised standard in practice is EN ISO 15223-1:2021, "Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements." It contains the symbols for manufacturer, manufacture date, expiry, lot number, serial number, single use, sterile, non-sterile, consult instructions for use, caution, and — critically — the MD symbol that satisfies the "indication that the product is a medical device" requirement of Section 23.2. Use the current edition of EN ISO 15223-1:2021. Do not copy symbols from competitor packaging or from outdated clip-art libraries — the meaning has moved between editions and the geometry is specified.

Any symbol not from a recognised standard must be described in writing in the IFU. An invented symbol with no explanation is a Section 23.1(h) finding.

## CE mark placement under Article 20

MDR Article 20 governs the CE marking of conformity for medical devices. The article requires that devices considered to be in conformity with the Regulation bear the CE marking set out in Annex V of Regulation (EC) No 765/2008. The CE marking must be affixed visibly, legibly, and indelibly to the device or its sterile packaging, where practicable and appropriate. Where this is not possible or warranted because of the nature of the device, the CE marking must be affixed to the packaging. The CE marking must also appear on any instructions for use and on any sales packaging. Where a notified body was involved in the conformity assessment procedure, the CE marking is followed by the identification number of that notified body. (Regulation (EU) 2017/745, Article 20.)

Three practical consequences. First, the CE mark is not decoration — it is a legal claim that the device has completed conformity assessment. A CE mark on a demo or prototype device is a placing-on-the-market problem, not a branding choice. Second, the notified body four-digit number appears with the CE mark only where a notified body was involved. A self-certified Class I device without a sterile function or measuring function does not have a notified body number next to its CE mark; adding one is wrong. A Class IIa or higher device must have it; omitting it is wrong. Third, the CE mark appears in multiple places — device or sterile packaging, instructions for use, sales packaging — and every copy must meet the same geometry and legibility rules.

The geometry of the CE mark itself is set in Annex II of Regulation (EC) No 765/2008: specific proportions, a minimum height of 5 mm unless the device is too small, and the prohibition on compressing or distorting the glyph to fit a layout. Start the label design from the CE block and fit the brand around it, not the other way around.

## UDI placement under Article 27

MDR Article 27 establishes the Unique Device Identification system and requires that the UDI carrier be placed on the label of the device and on all higher levels of packaging. The UDI is composed of a UDI-DI (device identifier, identifying the specific device model) and a UDI-PI (production identifier, identifying the specific production instance — lot, serial, expiry, or manufacturing date depending on the device). Both must be carried on the label in machine-readable and human-readable form, according to the rules of a Commission-designated issuing entity. (Regulation (EU) 2017/745, Article 27.)

The UDI obligation phases in by device class and by date. When it applies, it applies in full: the carrier on the label, the human-readable interpretation next to it, the UDI record in Eudamed, and the escalation of the carrier up through the packaging hierarchy. Skipping the UDI-PI and printing only the UDI-DI is a common error — the machine-readable code and the human-readable interpretation must match, and both must carry the full UDI required for the device.

See the dedicated post on UDI for the full walk-through of issuing entities, format rules, and Eudamed registration.

## Language coverage under Article 10(11)

MDR Article 10(11) requires the manufacturer to ensure that the device is accompanied by the information supplied under Section 23 of Annex I in an official Union language or languages determined by the Member State in which the device is made available to the user or patient. (Regulation (EU) 2017/745, Article 10(11).) Each Member State publishes its own language requirement, and the requirements differ between professional-use devices and lay-user devices.

The practical consequence is that language is a market-entry decision, not a design decision. Before adding a country to the market-entry plan, map its language requirement for your device's user group. Commission translations from a medical-device-qualified translator and keep every language version under document control per EN ISO 13485:2016+A11:2021 — a translated label or IFU that drifts from the master is a document control finding. Every added language multiplies the cost of every future label revision, which is another reason to subtract the label to its minimum required content.

## The Subtract to Ship angle on labelling

The label invites the same bloat as every other part of the regulatory file. Every team member wants their warning added. Marketing wants their tagline on the front. Legal wants a disclaimer. The cumulative result is a label that is simultaneously too crowded to read and still missing mandatory Section 23.2 elements, because nobody applied a checklist discipline to it.

Subtract to Ship for the label is the opposite move. Start from the Section 23.2 list, add the CE block from Article 20, add the UDI carrier from Article 27, add the symbols from EN ISO 15223-1:2021 that compress text into icons, and cut everything that does not trace to one of those sources. Every element on a compliant label should answer the question "which Section 23.2 subparagraph, which article, or which harmonised standard requires this?" If the answer is "marketing wanted it," it goes on the sales packaging or the IFU — not the immediate device label. See [the Subtract to Ship framework for MDR compliance](/blog/subtract-to-ship-framework-mdr) for the broader methodology.

## Reality Check — Where do you stand?

1. Do you have a Section 23.2 checklist that maps every applicable subparagraph to a specific location on your physical label, sales packaging, or IFU?
2. Is every element on your current label traceable to a Section 23.2 subparagraph, to MDR Article 20 (CE mark), to MDR Article 27 (UDI), or to EN ISO 15223-1:2021 (symbols)?
3. Does your CE block follow the geometry of Regulation (EC) No 765/2008 Annex II, with the correct notified body number (or no number) for your conformity assessment route?
4. Are all symbols on the label taken from the current edition of EN ISO 15223-1:2021 and explained in a legend in the IFU?
5. If your immediate device label is small, have you documented which Section 23.2 elements live on the device, which on the sales packaging, and which in the IFU — and verified the chain is continuous?
6. Does the UDI carrier on the label include both UDI-DI and UDI-PI, in machine-readable and human-readable form, from a Commission-designated issuing entity?
7. Have you mapped every target Member State to its language requirement under Article 10(11) for your device's user group?

## Frequently Asked Questions

**Where does MDR actually list what has to be on a device label?**
Annex I Chapter III Section 23.2 of Regulation (EU) 2017/745 is the legal source. It lists every particular that must appear on the label. Section 23.1 gives the general principles across all information supplied with the device, Section 23.3 covers sterile packaging, and Section 23.4 covers the instructions for use.

**Does the CE mark have to be on the device itself, or can it go on the packaging?**
Article 20 requires the CE marking to be affixed visibly, legibly, and indelibly to the device or its sterile packaging. Where this is not possible or warranted because of the nature of the device, it must be affixed to the packaging. The CE mark must also appear in the instructions for use and on any sales packaging. Small devices can carry the CE mark on the sterile or outer packaging where the physical label is too small.

**What do I do if my device is too small to carry every Section 23.2 element on the immediate label?**
Distribute the information across the layers. The immediate device label carries the items the user needs in the moment of use (manufacturer identification, device identification, lot or serial, UDI, CE mark, critical warnings). The sales packaging carries the rest of Section 23.2. The IFU carries detailed warnings and contraindications. The rule is that every required element appears somewhere in the information supplied with the device, not that every element must fit on the same physical surface.

**Can I use any symbol library for my label?**
Only symbols from a recognised standard are covered by Section 23.1(h) without further explanation. In practice the standard is EN ISO 15223-1:2021. Any symbol not from a recognised standard must be described in writing in the IFU. Invented symbols without explanation are a nonconformity.

**What language does the label have to be in?**
Article 10(11) leaves the language to the Member State in which the device is made available. Most Member States require the national language for devices supplied to lay users. Some accept English for devices supplied only to professional users. Check each target country before market entry and plan translations accordingly.

**Do I need a UDI carrier on my label from day one?**
The UDI obligation under Article 27 phases in by device class and by compliance date. Once it applies to your class, the carrier must appear on the label with both UDI-DI and UDI-PI, in machine-readable and human-readable form, from a Commission-designated issuing entity. See the dedicated UDI post for the phased dates and the issuing entities.

## Related reading

- [CE Marking Placement Under MDR](/blog/ce-marking-placement-mdr) — the geometry, placement, and notified body number rules of Article 20.
- [Instructions for Use Under MDR](/blog/instructions-for-use-mdr-compliant) — the Section 23.4 companion to the label.
- [Packaging and Sterile Barrier Information Under MDR](/blog/mdr-packaging-sterile-barrier-information) — Section 23.3 and how it connects to the label and IFU.
- [Symbols on Medical Device Labels (EN ISO 15223-1)](/blog/mdr-symbols-iso-15223-1) — the symbol library that compresses Section 23.2 text into icons.
- [UDI Under MDR — Articles 27 to 29](/blog/udi-under-mdr) — the UDI system, issuing entities, and label placement rules.
- [Language Requirements for Medical Device Labels in the EU](/blog/mdr-multi-language-ifu-translation) — Article 10(11) Member State by Member State.
- [Electronic Instructions for Use (eIFU) Under MDR](/blog/mdr-eifu-electronic-instructions) — when electronic IFUs are allowed and the conditions that apply.
- [Misleading Claims Under MDR](/blog/misleading-claims-mdr) — the Article 7 boundary between the label, the IFU, and marketing.
- [Common Labelling Mistakes Startups Make Under MDR](/blog/common-labeling-mistakes-startups-mdr) — the ten recurring failure modes that connect directly to Section 23.2 and 23.4.
- [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) — the methodology behind cutting the label to what the regulation actually requires.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10(11) (language of information supplied with the device), Article 20 (CE marking of conformity), Article 27 (Unique Device Identification), Annex I Chapter III Section 23.1 (general principles for information supplied with the device), Section 23.2 (information on the label). Official Journal L 117, 5.5.2017.
2. Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, Annex II (CE marking geometry). Official Journal L 218, 13.8.2008.
3. EN ISO 15223-1:2021, "Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements".

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*This post is part of the Technical Documentation & Labeling cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. A compliant label is not the product of creative writing; it is the product of reading Annex I Chapter III Section 23 in full, mapping every required element to a physical location, and letting the regulation — not the brand layout — decide what appears where.*

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*This post is part of the [Technical Documentation & Labeling](https://zechmeister-solutions.com/en/blog/category/technical-documentation) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*