The Actors module of the Swissdamed medical devices database is currently operational as of August 6, 2024. This module facilitates the registration and acquisition of a Swiss Single Registration Number (CHRN) for manufacturers, importers, authorized representatives, and manufacturers of procedure packs and systems. In accordance with earlier pronouncements, this number uniquely identifies these economic operators all over Switzerland.
CRN Registration
- After a device is placed on the Swiss market, manufacturers, importers, and authorized representatives in Switzerland have a three-month window to register and obtain their CHRN.
- Nearly 3,700 economic operators have already registered in the system, and their data will be directly transferred to the new system. A letter to their listed contact persons will provide them with all the details on what to do next.
New Swiss Database
- In order to reduce administrative burdens for economic operators and guarantee compliance with both Swiss and EU rules, Swissdamed is designed to closely mirror the corresponding modules of the European database, EUDAMED.
- The second module of Swissdamed, “Devices”, is slated to become operational in 2025. Initially, that module will just require MDR and IVDR device registrations using XML files used for EUDAMED. Following the full database development and revisions to the MedDo and IvDo legal texts, complete device registration will become mandatory.
Alignment with IVDR Extensions and Swissdamed Registration
The Swiss Federal Department of Home Affairs (FDHA) declared on August 14, 2024, that it will update Swissdamed registration rules, streamline labelling regulations, and align with the EU’s extension for legacy IVDs
The EU’s Regulation which was adopted on June 13, 2024, introduced significant modifications to the IVDR. One of these modifications is the extension of the validity period for certificates issued under the former IVDD regulation. This extension is set until 2027, 2028, or 2029 depending on the device classification.
Switzerland complies closely with EU standards to preserve market access and guarantee efficacy and safety. By bringing Swiss regulations into line with the new EU regulations, this decision to implement EU amendments including the extended validity of IVDD certificates nearing expiration ensures a steady IVD device supply throughout the transition.
The new transitional periods are:
- 31 December 2027 – Class D and devices with an IVDD CE Certificate
- 31 December 2028 – Class C
- 31 December 2029 – Class B and A sterile
All devices must be registered in the centralised Swissdamed database. Voluntary registration for some modules will commence in 2025, while mandatory registration is scheduled to begin in 2026. The Actors module is available for registration as of August 2024.
