Labelling Choices: One Trilingual Instructions Booklet or Three Separate Booklets

This article is issue 24 of Volume 3, Registration Dossiers and Technical Requirements, of the 50-article series on medical device registration in Switzerland. Together with the other nine issues in this volume it forms a complete deliverable on this topic; the publication timestamp, issue number, title and unique URL are shown in the table below.

1. Key takeaways

The default answer is trilingual product information; reduced languages are a narrow path. MedDO Art. 16(2) requires product information — the label and the instructions for use, following Chapter III of EU MDR Annex I — to be written in the three Swiss official languages, German, French and Italian; symbols established by technical standards may replace text. Art. 16(3) sets four conditions for reduced languages or the use of English, and all four must be satisfied simultaneously: supply is exclusively to professional users or the device is custom-made or for own use; the users have the requisite professional and language qualifications and have agreed; the protection of patients, users and third parties remains assured; and the effectiveness and intended use of the device are not affected. The four conditions are cumulative — if one fails, the whole route fails. Whether to print one booklet or three is therefore essentially a printing and distribution cost question, not a compliance route question, unless you can evidence all four conditions in full.

2. Legal basis

3. Expert insights

1. The trade-off between one booklet and three lies in the supply chain, not in compliance. A combined booklet (three languages side by side in one document) has one material number, one version, and no risk of shipping the wrong language; its weaknesses are page inflation, costly re-layout, and the fact that every revision requires all three languages to be finalised at once — any lagging language holds up the whole booklet. Separate booklets (German, French and Italian each in their own document) can be revised independently and each is thinner, but material numbers multiply and the probability of shipping a wrong-language version rises. Shipping the wrong language in Switzerland is treated as product information that does not comply with Art. 16(2) — a compliance problem, not a logistics slip. The decision criterion is the language sensitivity and revision frequency of the product line: frequently revised multilingual lines fit separate booklets better (practical estimate).

2. User agreement is the most fragile link. The second condition of Art. 16(3) requires users to have the requisite professional and language qualifications and to have agreed. That agreement must be demonstrable: verbal consent, absence of relevant clauses in procurement contracts, or inability to point to a specific user institution will all sink the reduced-language claim. The counterweight is real life: Swiss healthcare institutions do broadly accept English instructions for use, and many importers operate this way, but regulatory non-enforcement is not the same as compliance with Art. 16(3). Once a serious incident is reported under Art. 66, the language question will be re-examined alongside it, and at that point the burden of proof lies with the manufacturer.

3. Symbols save space but cannot eliminate all text. Art. 16(2) permits symbols established by technical standards to replace text, which is a legitimate path to slim labels. But the use of symbols has a defined scope: warnings, contraindications and operational steps that require precise semantics cannot be carried by symbols. The same provision, Art. 16(7), also prohibits misleading or contradictory information about the intended purpose, safety and performance, and Art. 69(2) extends the same prohibition on misleading claims to advertising. If the language versions diverge in their statements, both provisions can be triggered at the same time.

4. Practical recommendations

1. Prepare product information in the three official languages by default; take the reduced-language or English route only when all four conditions can be evidenced one by one.
2. Formalise any reduced-language decision in a written justification mapped point by point to the four conditions of Art. 16(3), with evidence of user qualifications and agreement attached.
3. Decide one booklet versus three by revision frequency and shipping risk: frequent revisions favour separate booklets, weak material management favours the combined booklet.
4. Establish a consistency review process across the language versions: any revision in one language must be checked against the other two, to avoid triggering Art. 16(7) and Art. 69(2).
5. When affixing the Swiss conformity mark of Annex 5 or the EU CE mark to the label, note that under Art. 13(3) the number of the designated body must accompany the conformity mark, with placement following the hierarchy of Art. 14.

5. Verification checklist

• □ Product information covers German, French and Italian, or a written justification for reduced languages exists
• □ If the reduced-language route is taken, evidence exists for each of the four conditions of Art. 16(3), especially user qualifications and agreement
• □ Symbol replacements are checked against the technical standards cited, and symbols are not used for content requiring precise semantics
• □ A consistency review across the language versions has been performed, with no contradictory statements
• □ Placement of the conformity mark and the designated body number complies with Art. 13 and Art. 14
• □ Advertising and promotional materials have been screened against the prohibition in Art. 69(2)

Legal information verified as of 29 October 2026.

GRZAN supports manufacturers with registration documentation and conformity files for the Swiss market: trilingual labelling and instructions for use, reduced-language justifications under Art. 16(3), symbol strategy reviews and multilingual consistency checks. Our regulatory writers keep your product information compliant across German, French and Italian. For assistance, contact GRZAN at info@grzanglobal.com.