Integrity and transparency: the scope of VITH (SR 812.214.31) for device manufacturers

This article is the 47th 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

The Swiss integrity and transparency rules do not apply to medicines and devices in the same way. The Ordinance on Integrity and Transparency, VITH, SR 812.214.31, entered into force on 1 January 2020, but for medical devices only the transparency rules currently apply, under TPA Art. 56 and VITH Art. 10 onwards; the integrity rules have not yet been extended to devices. The compliance red line for device companies is therefore disclosure rather than prohibition. The focus is on the verifiable disclosure of economic benefits such as discounts and rebates, not on a blanket ban on providing them. Companies that misread this boundary in either direction get into trouble: those who assume everything is permitted build disclosure systems too late, and those who assume the integrity rules already apply shut down legitimate scientific and clinical cooperation that the law does not actually restrict.

2. Legal basis

3. Expert insights

1. The legislative timeline reveals the asymmetry of scope. The integrity and transparency provisions of the TPA were added in 2016, and the VITH entered into force on 1 January 2020, so the two steps follow each other closely, indicating a concentrated legislative effort on the therapeutic products sector. For devices, however, the official position is explicit: only the transparency rules currently apply. The judgement is that the legislator first solved the visibility problem, the disclosure of economic benefits, and left the question of whether such benefits may be given at all, the integrity rules, for later evaluation. The counterpoint is practical: a company that wrongly assumes the integrity rules already apply, and therefore bans scientific support and the provision of demonstration units outright, over-restricts normal commercial and clinical collaboration in ways the law does not require.

2. The real burden of the transparency rules lies in the granularity of records and disclosure. What the transparency rules demand is verifiable disclosure of economic benefits granted to healthcare professionals and institutions. The difficulty is not the principle but the categories: how discounts, rebates, sponsorships, demonstration units and training support are classified; by which entity and over which period they are aggregated; and which records serve as evidence when a figure is disputed. As a practical estimate, start by building classification rules by transaction type and then unify the aggregation logic across entities and periods. Granularity that is too coarse distorts the disclosure; granularity that is too fine inflates compliance operating costs. The right level is the one that a third party could verify from your records without needing a further explanation from your team.

3. The overlap with advertising rules and vigilance rules requires one combined map. TPA Art. 55 and Art. 56 deal with the integrity and transparency of economic benefits; MedDO Art. 69(2) deals with misleading advertising; MedDO Art. 65-67 and TPA Art. 59 deal with the reporting of safety events. The three lines are independent, yet a single market activity can trigger all of them at once: a promotional event for a hospital involves advertising statements, may involve hospitality and sponsorship subject to transparency disclosure, and if a device malfunctions on site, vigilance duties attach as well. Splitting these three rule sets across different departments with no joint review is a common organisational source of risk, because each department assumes another one has covered the intersection.

4. Practical recommendations

1. Fix the internal position in writing: for the device business, only the transparency rules currently apply under TPA Art. 56 and VITH Art. 10 onwards, while the integrity rules do not, so compliance requirements are neither misread nor over-applied.
2. Build a ledger of economic benefits classified by transaction type, covering discounts, rebates, sponsorships, demonstration units and training support, with unified aggregation by entity and period.
3. Retain verifiable evidence such as contracts, invoices, payment records and the confirmation of the sponsored party, so every disclosed figure can be validated by a third party.
4. Consolidate the compliance review of market activities into a single joint sign-off covering both advertising statements under Art. 69(2) and Art. 16(7) and transparency disclosure.
5. Monitor amendments to the VITH and the TPA; once the integrity rules are extended to devices, the existing arrangements for scientific support and promotion must be re-evaluated immediately.

5. Verification checklist

• □ The internal compliance manual records the official position that only the transparency rules currently apply to devices, with the supporting provisions cited.
• □ The ledger of economic benefits has classification and aggregation rules by transaction type.
• □ Every disclosed item is traceable to a contract, invoice or payment record.
• □ Market activities undergo a joint advertising and transparency sign-off.
• □ Distributor contracts contain binding clauses on promotional conduct and transparency disclosure.
• □ A tracking and review mechanism for VITH and TPA amendments is in place.

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 builds transparency ledgers under TPA Art. 56 and VITH Art. 10 onwards, integrates advertising and disclosure sign-offs and tracks legislative changes affecting device marketing. For support with your Swiss post-market obligations, contact info@grzanglobal.com.