SWISSMEDIC, the Swiss Agency responsible for the authorization and oversight of medicinal products and medical devices, recently announced the launch of “Swissdamed,” a new platform for medical devices, beginning in late August 6, 2024. The rollout is occurring in phases, with the initial release of the “Actors” module, which allows economic operators to register through the web portal.
Swissdamed aims to offer a comprehensive overview of medical devices, including in vitro diagnostic devices, available in the Swiss market, and the responsible economic operators. The database will eventually collect, process, and publish information about these devices and companies (e.g., manufacturers), enhancing transparency and improving public and healthcare professionals’ access to information.
Due to the lack of an updated mutual recognition agreement (MRA) between Switzerland and the EU, Swissmedic directly handles the registration of economic operators and medical devices, including in vitro diagnostics. Manufacturers must comply with Swiss ordinances (MedDO and IvDO) as well as specific EU regulations, which will be enforced in Switzerland starting in 2026, once the necessary database is available.
The Swissdamed platform supports the application of Swiss medical device regulations. It consists of two main modules: the “Actors” module for company registration, available from August 2024, and the “Devices” module for device registration, which is still under development and will be partially available in 2025 for voluntary registration. Successful pilot phases with Swiss operators have helped improve the platform, and further enhancements are planned with stakeholder involvement. To align with EU regulations and minimize effort for economic operators, Swissdamed has been modelled after the European database EUDAMED.
Economic operators must register with Swissmedic within three months of placing a device on the Swiss market, as per MedDO and IvDO regulations. Starting from 6 August 2024, registrations, changes to the Swiss Single Registration Number, and mandate notifications must be submitted via the Swissdamed platform, with evidence of domicile in Switzerland required.
For operators already registered with Swissmedic, they have been informed of the next steps by their designated contact person. Swissmedic assigns, upon request, a Swiss Single Registration Number (CHRN). The CHRN is a unique identifier consisting of the prefix “CHRN,” an abbreviation for the operator’s role, and an eight-digit number. This applies to Swiss manufacturers, authorized representatives, importers, and manufacturers of systems and procedure packs.
The “Devices” module will be rolled out in stages, with the first phase launching in 2025, allowing the registration of “Regulation Devices” (MDR and IVDR) using XML files in the EUDAMED format. Further releases will complete the module. Device registration will only become mandatory once Swissdamed is fully developed and the necessary amendments to the MedDO/IvDO are made.
Swissdamed is aligned with EUDAMED in the management of the Unique Device Identification (UDI) system, for which the European Commission has released a guidance document for providing answers to frequently asked questions and links to additional resources.
As the European Commission has designated a new issuing entity for the UDI system in medical devices, in addition to the three existing entities outlined in EU regulations MDR and IVDR, the current list of issuing entities, also applicable for Swissdamed, includes:
- GS1 AISBL,
- Health Industry Business Communications Council (HIBCC),
- ICCBBA,
- Informationsstelle für Arzneispezialitäten – IFA GmbH.
All relevant specifications and additional information will be published on the Swissdamed page as soon as available.
All economic operators already registered with Swissmedic and holding a CHRN have been requested to validate their data migrated to Swissdamed within three months, through a letter addressed to their Swissmedic contact person.
As of late September 2024, Swissmedic data indicates that nearly 1,000 operators have completed this validation. The deadline for validation is set for November 13, 2024.
All registered Swiss manufacturers are required to validate their data to help ensure data integrity and reliability within the Swissdamed “Actors” module. This data accuracy is essential for the effective rollout of the “Devices” module and, ultimately, for providing a comprehensive view of the Swiss medical devices market.
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/chrn-swiss-single-registration-number.html