Swissmedic, the Swiss Agency for Therapeutic Products, has announced the availability of the “Legacy devices” registration system. As of February 2026, companies can register their legacy devices to ensure compliance with Swiss medical device regulations.
This development is particularly relevant to clinical, quality, and regulatory teams in the medical device industry.
What changed?
The introduction of the legacy devices registration system allows companies to register their existing medical devices, which were previously not required to be registered.
Why is this necessary?
This registration system ensures that all medical devices, including legacy devices, meet the necessary safety and performance standards in Switzerland.
Who is affected?
Clinical, quality, and regulatory teams in the medical device industry are directly affected by this change. Companies that manufacture or distribute medical devices in Switzerland need to register their legacy devices.
How to register?
Companies can register their legacy devices on the Swissmedic website. The registration process involves providing detailed information about the device, including its intended purpose, performance, and safety characteristics.
What information is required?
Companies need to provide information about the device’s design, manufacturing process, and labeling. Additionally, they must submit documentation demonstrating the device’s compliance with relevant safety and performance standards.
Frequently Asked Questions
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What is a legacy device?
A legacy device is a medical device that was previously not required to be registered in Switzerland.
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Why do I need to register my legacy devices?
You need to register your legacy devices to ensure compliance with Swiss medical device regulations and to demonstrate that your devices meet the necessary safety and performance standards.
Conclusion
The introduction of the legacy devices registration system is an important step towards ensuring the safety and effectiveness of medical devices in Switzerland. Companies must register their legacy devices to comply with Swiss regulations.
Disclaimer
This information is intended for professionals in the medical device industry and is not meant to provide legal advice.
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-legacy-devices.html