Notification of Medical Devices Placed on the Swiss Market – Swissmedic Procedure

Overview and Legal Basis

Since the revision of the Medical Devices Ordinance (MedDO) effective 26 May 2021, the previous notification procedure for medical devices has been replaced by mandatory registration in the Swiss Product Registration Database. This electronic registration serves as the official notification of devices placed on the Swiss market and is required for all medical devices (including in vitro diagnostics, custom-made, and investigational devices under specific conditions). The process ensures traceability, supports market surveillance, vigilance activities, and compliance verification by Swissmedic. Meldung Medizinprodukten - Swissmedic

Who Must Notify/Register

Registration is mandatory for:

• Manufacturers (Swiss or foreign) placing devices on the Swiss market.
• Authorised Representatives (CH-REP) for non-Swiss manufacturers.
• Importers introducing devices into Switzerland.

Pure exporters without Swiss market placement are exempt. The responsible economic operator must complete registration before the device is made available on the Swiss market.

Registration Content and Requirements

Key data to be submitted includes:

• Device identification (UDI-DI where applicable, or Swiss-specific identifiers).
• Economic operator details (CHRN – Swiss Single Registration Number).
• Conformity assessment documentation (certificates, declarations of conformity).
• Classification, intended purpose, and risk class.
• Labelling and instructions for use (in required Swiss languages).
• Vigilance-related information (if relevant).

For legacy devices (previously placed under old directives), transitional provisions apply with specific deadlines.

Submission Process

• All registrations are submitted exclusively through the Swissmedic e-Business portal.
• Step-by-step workflow: Obtain CHRN → Create/update operator profile → Register device(s) or families → Upload supporting documents.
• Validation rules provide immediate feedback on completeness and format.
• Certain changes (e.g., significant modifications, certificate updates) require amendment notifications.

Consequences of Non-Compliance

Failure to register before market placement renders the device non-compliant. Swissmedic may:

• Prohibit market availability.
• Order withdrawal or recall.
• Impose administrative sanctions or fees.

Prompt registration and updates are essential to avoid enforcement actions.

Additional Support and Resources

Swissmedic provides detailed guidance documents, FAQs, technical specifications, and support contacts for the registration process. The e-Business portal includes a test environment (Playground) for practice submissions. Annual statistics on registered devices are published to enhance transparency.

This registration-as-notification system strengthens Switzerland's medical device regulatory framework, ensuring effective oversight, rapid response to safety issues, and alignment with international standards while maintaining national control. Full instructions, portal access, and related resources are available on the Swissmedic notification page. Meldung Medizinprodukten - Swissmedic