Labelling and Instructions for Use under MDR Annex I Chapter III

Labelling and instructions for use are the most frequently inspected surfaces of any medical device on the EU market. This article explains what MDR Annex I Chapter III Section 23 requires, how the electronic instructions for use regime works, and which label elements are most often missed in market surveillance checks.

1. Key takeaways

Section 23 of Chapter III of Annex I defines the content requirements for device labelling and the information supplied with the device, that is, the instructions for use. Instructions for use may be supplied electronically, but the applicable conditions, the exceptions and the alternative means of supply are governed by Implementing Regulation (EU) 2021/2226, which was amended in 2025 by Implementing Regulation (EU) 2025/1234. Language requirements follow the official Union language determined by the Member State in which the device is supplied (practical estimate: each country must be checked individually).

Three operational points follow. Labelling, packaging and the accompanying information are three distinct carriers with non-overlapping requirements. The UDI carrier, the authorised representative information and the warning information are the three high-frequency mandatory checks on any label. And the electronic route for instructions for use is a conditional permission defined in an implementing regulation, not a general licence to withdraw paper versions across the portfolio.

2. Legal basis

The table below lists the provisions and instruments cited in this article.

Because Section 23 operates at three carrier levels and the electronic regime is set in a separate implementing regulation, the label artwork review should always be run against both instruments together rather than against one alone.

3. Expert insights

Insight one: the label, the packaging and the accompanying information are three different carriers with non-overlapping requirements.

Section 23 addresses the information on the device label, the information on the packaging, and the information in the instructions for use supplied with the device, each with its own item list. The recurring failures in market surveillance are information present in the instructions for use but missing from the label, or present on the shipping carton but missing from the unit pack. Both patterns are judged nonconform because the requirements apply layer by layer rather than to the documentation set as a whole.

Insight two: the UDI carrier, the EC REP information and the warning information are the three high-frequency mandatory label checks.

The label must carry the UDI carrier (Article 27(4)), the name and address of the authorised representative where applicable, and the warnings and precautions required by Section 23. Importers must additionally, under Article 13, indicate on the device, its packaging or accompanying documents their own name, registered trade name or registered trademark, their registered place of business and the address at which they can be contacted. This importer block is the single most frequently omitted label element in practice.

Insight three: electronic instructions for use are not a general permission to cancel the paper version.

Implementing Regulation (EU) 2021/2226 defines which devices may supply instructions for use electronically, under which conditions, and what the supplementary requirements for the paper version are; it was amended in 2025 by (EU) 2025/1234. Whether the electronic route may be used must therefore be assessed clause by clause against the implementing regulation. Deciding by reference to prevailing industry practice alone creates a compliance gap that a notified body or authority can close at any audit.

Insight four: language requirements are determined at Member State level.

Within the MDR framework, the information supplied with the device must be provided in the official Union language or languages determined by the Member State in which the device is supplied. Which language applies, and whether several languages must appear in parallel, depends on each Member State (practical estimate: check country by country; this site does not give per-country conclusions). The language version list is therefore a market-specific deliverable, not a single EU-wide decision.

In operational terms, the three-level checklist should be applied at every artwork revision, not only at first release, because label elements such as the importer block, the authorised representative and the UDI carrier can each change independently of the others. A single change ticket should therefore trigger verification of all three levels before the artwork is released to production.

4. Practical recommendations

1. Produce a three-level label checklist covering the device label, the unit pack and the shipping carton, and verify the information items at each level separately.
2. Include the importer information required by Article 13 on the label or the accompanying documents, and update it whenever the importer changes.
3. Before adopting electronic instructions for use, check the applicability conditions clause by clause against (EU) 2021/2226 as amended in 2025.
4. Determine the language versions from the list of target Member States and keep controlled copies of every released version.
5. Route label changes through the change management procedure and assess whether the change triggers a notification duty towards the notified body.

5. Verification checklist

• □ Information items have been verified level by level across the label, the unit pack and the shipping carton
• □ The UDI carrier is placed on the label and on all higher levels of packaging
• □ The authorised representative name and address appear on the label (where applicable)
• □ The importer name, registered place of business and contact address are included (Article 13)
• □ The applicability conditions for electronic instructions for use have been checked against (EU) 2021/2226 and (EU) 2025/1234
• □ The language version list for the target Member States has been fixed (practical estimate, country by country)

Regulatory information verified as of 2026-10-29.

GRZAN supports medical device manufacturers entering and maintaining the EU market under Regulation (EU) 2017/745. Our team audits labelling and instructions for use against MDR Annex I Chapter III Section 23, assesses the electronic instructions for use route under Implementing Regulation (EU) 2021/2226, and coordinates language version control across Member States. For technical file and conformity support for the EU MDR market, contact info@grzanglobal.com.