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January 12, 2026
Approximately 5 minutes
Notification of In Vitro Diagnostic Devices Placed on the Swiss Market – Swissmedic Requirements
Notification of In Vitro Diagnostic Devices Placed on the Swiss Market – Swissmedic Requirements
Legal Basis and Transition
The notification obligation for in vitro diagnostic (IVD) medical devices has been replaced by mandatory registration in the Swiss Product Registration Database since the revision of the Medical Devices Ordinance (MedDO) effective 26 May 2021. This aligns with the EU IVDR 2017/746 requirements adopted in Switzerland. All IVDs placed on the Swiss market – including those with CE marking under transitional provisions – must be registered before being made available. The registration serves as the official notification and supports market surveillance, vigilance, and traceability. Meldung IVD - Swissmedic
Who Must Register IVDs
Registration is required by:
- Manufacturers (Swiss or foreign) placing IVDs on the Swiss market.
- Swiss Authorised Representatives (CH-REP) designated by non-Swiss manufacturers.
- Importers introducing IVDs into Switzerland.
Pure exporters without Swiss market placement are exempt. The responsible economic operator must ensure registration prior to market availability.
Registration Scope and Data Requirements
All IVDs are subject to registration, regardless of risk class (A to D under IVDR classification). Key information to submit includes:
- UDI data (UDI-DI and UDI-PI where applicable, mandatory for higher-risk IVDs).
- Economic operator details (CHRN – Swiss Single Registration Number).
- Conformity assessment (certificates from notified bodies, declarations of conformity).
- Device information (classification, intended purpose, analytical/clinical performance data references).
- Labelling and IFU (availability in German, French, Italian as required).
- Basic UDI-DI for grouping where relevant.
Legacy IVDs (placed under old IVDD) benefit from transitional deadlines aligned with EU provisions.
Submission Process via e-Business Portal
- All registrations occur exclusively through the Swissmedic e-Business portal (medical devices module).
- Workflow: Obtain CHRN → Maintain operator profile → Register IVD (single or family/group) → Upload supporting documents → Validate and submit.
- Real-time validation flags errors in format, mandatory fields, or inconsistencies.
- Amendments for changes (e.g., certificate updates, labelling revisions, ownership transfer) must be submitted promptly.
Compliance and Enforcement
Non-registration before market placement constitutes non-compliance. Swissmedic may:
- Prohibit further supply.
- Order withdrawal/recall.
- Initiate administrative measures or sanctions.
Accurate and timely registration is critical to avoid enforcement actions and ensure legal market access.
Guidance and Support
Swissmedic publishes dedicated guidance for IVD registration, including checklists, technical specifications for UDI/UDI-DI, FAQs, and examples. The portal offers a test environment (Playground) for practice. Contact points and support are available for clarification.
This mandatory registration system for IVDs enhances Switzerland's regulatory control, ensures rapid identification in vigilance cases, and facilitates alignment with international standards while maintaining national oversight. Full details, portal access, forms, and resources are available on the Swissmedic IVD notification page. Meldung IVD - Swissmedic
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