Related Legislation
Overview
In addition to the TPA, MedDO, IVDO, and ClinO-MD, several other Swiss laws may apply to specific medical device types or circumstances.
The Transplantation Act (Transplantationsgesetz) governs the removal, allocation, and transplantation of organs, tissues, and cells of human or animal origin. Medical devices that incorporate human or animal tissues or cells (xenografts, tissue-based devices) must comply with Transplantation Act requirements in addition to MedDO/IVDO requirements. These requirements include controls on procurement, processing, testing, and traceability of the biological component. Swissmedic is the federal competent authority for oversight of tissue and cell-based medical devices.
Radiation Protection Act (SR 814.50)
The Radiation Protection Act applies to medical devices that emit ionising radiation (X-ray equipment, nuclear medicine systems, radiation therapy devices). Such devices must comply with both MedDO technical requirements and Radiation Protection Act requirements. The Federal Office of Public Health (FOPH) and cantonal authorities share oversight of radiation protection.
Federal Data Protection Act (nFADP, SR 235.1)
The revised Federal Data Protection Act (nFADP), which entered into force in September 2023, governs the processing of personal data including health data in Switzerland. Medical devices that process, store, or transmit patient data (connected devices, SaMD, imaging systems) must comply with nFADP requirements — including data security requirements, privacy by design, and data breach notification obligations to the Federal Data Protection and Information Commissioner (FDPIC).
Cantonal Health Laws
Cantonal (state) health laws regulate the practice of medicine and healthcare within each canton. While medical device market access is a federal matter, certain aspects of healthcare practice using medical devices — including professional licensing, hospital accreditation, and local inspection — are governed at the cantonal level. Cantonal health authorities may interact with Swissmedic in market surveillance activities.
Transplantation Act (SR 810.21)
The Transplantation Act (Transplantationsgesetz, SR 810.21) governs the removal, allocation, and transplantation of organs, tissues, and cells of human or animal origin. Medical devices that incorporate human or animal tissues or cells (xenografts, tissue-based devices) must comply with Transplantation Act requirements in addition to MedDO/IVDO requirements. These requirements include controls on procurement, processing, testing, and traceability of the biological component. Swissmedic is the federal competent authority for oversight of tissue and cell-based medical devices.
Official Sources
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