Summary

The Federal Department of the Interior (FDI) opens a consultation on May 6, 2026 regarding amendments to the Ordinance on Integrity and Transparency in the Medicinal Products Sector (OITM). The revision extends integrity requirements to medical devices, as decided by Parliament in March 2019. The revised Article 55 of the Medicinal Products Act (MPA) is to come into force together with the partially revised OITM. The consultation period runs until August 25, 2026.

Persons

  • Federal Department of the Interior (Federal authority)

Topics

  • Medicinal products law
  • Medical devices
  • Transparency and integrity
  • Consultation procedure

Clarus Lead

The extension of integrity requirements to medical devices closes a regulatory gap that has existed since Parliament's decision in 2019. With this measure, transparency requirements that previously applied only to pharmaceuticals are now being extended to the medical devices sector – a step intended to strengthen the trustworthiness of business relationships throughout the medicinal products sector. The seven-week consultation period allows stakeholder groups to submit comments on practical implementation.

Detailed Summary

The consultation concerns the partial revision of the OITM in the context of a comprehensive revision of medical device law. The legislature had already recognized in 2019 that the integrity requirement – which is intended to ensure transparency and independence in business relationships between manufacturers and professionals – had only been applied to pharmaceuticals. This asymmetry is to be remedied by extending it to medical devices.

The consultation is directed at cantons, professional associations, industry, and other stakeholders. Consultation documents are available on the fedlex.data.admin.ch platform. Questions can be directed to the communication office of the Federal Chancellery.

Key Points

  • Integrity requirements are being extended to the medical devices sector for the first time
  • Parliamentary decision from 2019 is being implemented after seven years of preparation
  • Consultation period: May 6 to August 25, 2026

Critical Questions

  1. Evidence: What data demonstrates that the previous asymmetry between pharmaceutical and medical device regulation has led to integrity problems?

  2. Conflicts of Interest: How will it be ensured that medical device manufacturers are not disproportionately burdened by compliance costs during implementation?

  3. Causality: How does the practical application of integrity requirements differ between pharmaceuticals and medical devices, and what adjustments are necessary?

  4. Feasibility: What transition periods are provided for companies to adapt their business processes to the new requirements?

  5. Effectiveness: How will compliance with the extended integrity requirement be monitored and enforced?

Source Directory

Primary Source: Consultation Opening: Amendment to OITM – Extension of Integrity to Medical Devices – https://www.news.admin.ch/de/newnsb/7jwuVKiC0r95sRb6z5Inf

Supplementary Sources:

  1. Fedlex Consultation Platform: https://fedlex.data.admin.ch/eli/dl/proj/2026/10/cons_1
  2. Swiss Federal Chancellery: https://www.bk.admin.ch

Verification Status: ✓ May 6, 2026

This text was created with the support of an AI model. Editorial responsibility: clarus.news | Fact-checking: May 6, 2026