Important News from Swiss Medtech for medical device Manufacturers, Importers and Distributors!

Swiss flag

New guidelines have been released detailing the regulatory requirements for placing “legacy devices” on the Swiss market.

This is essential to ensure you can sell-off all your legacy medical devices after 26.05.2024. It is particularly critical for devices that have not yet been recertified under the Regulation (EU) 2017/745 – MDR.

What you need to know:

  • Deadline: Placing devices on the Swiss market by 26 May 2024 to continue to be made available.
  • Compliance: Ensuring legacy devices meet Swissmedic’s requirements without lowering safety or quality.
  • Documentation: It’s vital to document the “placing on the market” for devices to demonstrate compliance.

This guidance helps prevent the unnecessary disposal of compliant medical devices and addresses potential shortages, ensuring the availability of critical health devices in Switzerland.

Here you can find Swiss Medtech Guidance document.