Summary

On May 6, 2026, the Federal Council submitted an ordinance amendment for consultation that extends the integrity requirement to medical devices. Previously, the requirement – which stipulates that prescription-only medicinal products should be prescribed free of financial incentives – applied only to medicinal products. The regulation is now to apply to medical devices such as MRI machines, hip implants, or eyeglasses. Parliament had decided on this expansion in 2019. The consultation period runs until August 25, 2026.

Persons

  • Federal Council (collectively)

Topics

  • Medicinal Products Act
  • Medical devices
  • Integrity requirement
  • Transparency in healthcare

Clarus Lead

The expansion of the integrity requirement addresses a regulatory gap: while medicinal products are already subject to transparency requirements, medical devices could previously be influenced through financial incentives. With this ordinance amendment, doctors, pharmacists, and hospitals are to select medical devices in the future solely according to medical criteria – a step intended to strengthen patient safety and cost-efficiency in the healthcare system. The seven-week consultation period until August 2026 gives stakeholders time to point out potential implementation obstacles.

Detailed Summary

The Ordinance on Integrity and Transparency in the Medicinal Products Sector (VITH) is being refined to exclude financial incentives in the dispensing and use of medical devices. The goal is to ensure that patients receive the product that is appropriate for them exclusively based on medical considerations. This affects a broad spectrum: from large equipment (MRI) to implants to everyday products such as eyeglasses or pregnancy tests.

Exceptions are provided for low-risk devices (Class I products such as plasters) and medical devices for self-use without prior professional consultation (such as contact lenses). Additionally, medical device-specific particularities are clarified: for example, the handling of samples or demonstration devices, which are relevant in clinical practice.

Key Points

  • The integrity requirement is being extended to medical devices for the first time, closing a regulatory gap.
  • Financial incentives in the selection and use of medical devices are to be excluded in the future.
  • Targeted exceptions for low-risk devices and self-use products preserve practicality.

Critical Questions

  1. Evidence: What data shows that financial incentives in medical devices actually lead to medically suboptimal decisions, and how robust are these findings?

  2. Conflicts of Interest: Which stakeholders (device manufacturers, clinics, doctors) have raised concerns about the ordinance amendment, and how transparently will these be documented in the consultation?

  3. Causality: How will it be demonstrated in practice that a product choice was motivated by financial incentives rather than legitimate medical reasons?

  4. Feasibility: How should control mechanisms be designed to ensure compliance with the integrity requirement among decentralized actors (clinics, practices) without overburdening compliance costs?

  5. Demarcation: What specific criteria distinguish Class I products (exempt) from higher-risk products (bound), and could borderline cases lead to legal disputes?

  6. Delay Risk: Could the expansion lead to delays in product launches if manufacturers need to rebuild compliance processes?

Sources

Primary Source: Integrity Requirement for Medical Devices – Federal Council Statement of May 6, 2026

Verification Status: ✓ 06.05.2026

This text was created with the support of an AI model. Editorial responsibility: clarus.news | Fact-checking: 06.05.2026