After some delays, the implementation of swissdamed – the Swiss Database on Medical Devices – is now picking up speed. Below you can find out what the current timetable looks like and where there is a need for action for players in the medical devices sector.
What is swissdamed?
swissdamed – the Swiss Database on Medical Devices – is a database to be set up by Swissmedic to implement the Swiss regulations for medical devices (MedDO) and in vitro diagnostics (IvDO). It is intended to provide a comprehensive overview of the life cycle of medical devices available in Switzerland and, in particular, to contribute to transparency and safety in the healthcare system. Due to the failure to update the Mutual Recognition Agreement (MRA) between Switzerland and the EU, Switzerland was unable to join EUDAMED and has to set up its own system for the registration of economic operators, medical devices and in vitro diagnostic medical devices.
How is implementation planned?
There have been delays in the implementation of swissdamed, which was originally planned for 2023. Swissmedic has now announced that the modules will be made available in stages:
- ACT module for registration of companies and economic operators – 2nd half of 2024
- Freely accessible platform swissdamed – 2nd half of 2024
- UDI module for registration of products - available as a minimum viable product 4 months after go-live of the ACT module
What does this mean for the registration of economic operators?
Swiss economic operators – i.e. Swiss manufacturers, authorized representatives and importers – must register with Swissmedic within three months of placing a medical device on the market in Switzerland for the first time. This obligation already exists, and registration is currently carried out using the CHRN application form. Once swissdamed has been activated, registration will take place via the ACT module.
Once the registration has been checked, Swissmedic will issue the economic operator with its Swiss Single Registration Number (CHRN). Each CHRN is unique and enables the economic operator to be uniquely identified. The CHRN consists of the abbreviation "CHRN", followed by the abbreviation for the role of the economic operator (e.g. MF for manufacturer/producer) and an eight-digit sequence of numbers (example: CHRN-MF-2345678).
In any case, it is advisable for economic operators to familiarize themselves with the relevant Swissmedic guidelines on the ACT module and to check their data after the transfer to the new system has occurred.
What does this mean in terms of product registration?
4 months after the ACT module goes live, the UDI module will also be available as a minimum viable product. Medical devices will have to be registered via this module. Swissmedic will define in guidelines and instructions how registration is to be done and which documents are required for it. In any case, it is recommended that this matter and the existing medical device documentation be addressed now.
Once the ACT and UDI modules have been implemented, further functions will be added later. Registration on swissdamed will only become mandatory once the corresponding changes to the MedDO / IvDO have been made and come into force. Until then, products can be registered on the platform voluntarily.
Conclusion
As the introduction of swissdamed draws closer, it is even more important that players in the medical devices sector get to grips with it, as there is a need for action. Our health law experts will be happy to assist you with questions on this and other health law issues.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.