Advertising compliance: the misleading-information red lines of Art. 69(2) and Art. 16(7)

This article is the 46th instalment of Volume 5, Post-market Compliance and Regulatory Developments, of the 50-part series on medical device registration in Switzerland. Together with the remaining nine articles of this volume it forms the complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below.

1. Key takeaways

Switzerland places advertising under the same anti-misleading rules that govern product information. Art. 69(2) subjects advertising to the prohibition of misleading statements, and Art. 16(7) prohibits misleading or self-contradictory statements on intended purpose, safety and performance. There is only one reliable test for the red line: every performance claim made in advertising must be traceable to a source in the technical documentation and the declaration of conformity, and it must not exceed the intended purposes covered by the conformity assessment. This test converts advertising review from a matter of taste into a matter of documentation. If a claim cannot be pointed to in a technical file, it does not matter how plausible or commonly used it is; under the Swiss rules it is exposed, and the exposure is shared by everyone who signed off the campaign.

2. Legal basis

3. Expert insights

1. Advertising and product information share one prohibitive rule, but apply to different objects. Art. 16(7) governs the product information, meaning the label and the instructions for use under Art. 16 para. 1, following Chapter III of Annex I to the EU MDR. Art. 69(2) extends the same anti-misleading logic to advertising directed at the public and at professionals. The substantive judgement is that the regulator does not distinguish between carriers; it asks only whether a statement could give the user a wrong understanding of the intended purpose, safety or performance. The counterpoint is a natural tension: advertising language is built for communicative efficiency and compression, while regulatory text is built for precision. A company cannot defend a claim by invoking the habitual phrasing of its marketing department; the standard is the regulation, not internal precedent.

2. The language requirement is the hidden threshold of advertising compliance. Art. 16 para. 2 requires product information to be drawn up in the 3 official languages, German, French and Italian, with symbols established by technical standards able to replace text. Para. 3 provides 4 conditions for using fewer languages or English: the device is supplied exclusively to professionals or is custom-made or made-to-order; the user has the necessary expertise and language competence and consents; protection of patients, users and third parties is still ensured; and the effective and intended use of the device is not compromised. On interpretation, note that these 4 conditions are cumulative and must all be met, with no exceptions for practical convenience. The trade-off is that reducing languages saves real money in translation and version management, but the moment the addressed group of patients or users widens, the conditions fail and already-placed materials must be reworked.

3. Contradictory information and misleading information are two distinct risks. Art. 16 para. 7 prohibits misleading statements and contradictory statements side by side. Contradictory information is not necessarily wrong, yet it creates divergent understanding: a contraindication listed in the German instructions but absent from the French version, or an advertising claim of intended use narrower than the instructions for use. In practice the second pattern is more common and more easily overlooked, because multilingual, multi-channel, multi-version materials updated in parallel will always contain a laggard channel, and any laggard produces an internal contradiction. This duty of consistent information shares its root with the requirement to report CHRN changes within 1 week under Art. 55 para. 2: both are continuing maintenance duties, not one-off filings.

4. Practical recommendations

1. Build a source index for every external performance claim, pointing to the specific section of the technical documentation, clinical evaluation or declaration of conformity that supports it.
2. Run advertising materials and trilingual product information through the same change process, so that an update on either side triggers a review of the other.
3. Before reducing languages, verify each of the 4 conditions of Art. 16 para. 3 and keep the written assessment on file; re-assess whenever the conditions change.
4. Maintain a version ledger across all channels, including the website, exhibition panels, distributor tender documents and social media, so the latest version reaches every channel.
5. Recall and archive historical materials that advertise discontinued products or uses beyond the intended purpose, so outdated material stops circulating.

5. Verification checklist

• □ All external performance claims are traceable to the technical documentation or the declaration of conformity.
• □ Advertising and trilingual product information are consistent in version and intended purpose.
• □ Decisions to reduce languages have been checked against each of the 4 conditions of Art. 16 para. 3 and archived.
• □ A multi-channel materials ledger exists, and obsolete versions have been recalled or marked as withdrawn.
• □ An advertising sign-off step is integrated into the duties of the PRRC or the regulatory function.
• □ Promotional materials for discontinued product items have been taken offline.

Legal information verified as of 29 October 2026.

GRZAN supports manufacturers entering or operating in the Swiss market with post-market compliance services, covering vigilance reporting, field safety corrective actions and Swissmedic inspection readiness. Our team reviews advertising claims against the technical documentation, manages the trilingual materials ledger and implements Art. 16 language-decision assessments. For support with your Swiss post-market obligations, contact info@grzanglobal.com.