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Deadlines IVDD and IVDR

ByAdrian Moser
Adrian Moser

The EU has extended the transition periods of the In Vitro Diagnostics Regulation (IVDR) 2017/746 from December 2021, according to the press release.

The challenge

The European Council and the European Parliament adopted the European Commission's proposal of October 14, 2021 without amendments. However, this does not change the date of entry into force of the regulation. This is still set for May 26, 2022. 

The solution

However, the new deadlines give manufacturers and notified bodies somewhat more leeway to subject IVD products to the conformity assessment procedure. Another change made by the European Commission in March 2023 concerns the elimination of the sales deadline.

The new regulations could therefore, for example, prevent IVDs from disappearing from the market en masse and safe products from being thrown away unnecessarily.

Things to know

For more information on all deadlines of In Vitro Diagnostics, please refer to the Swissmedic fact sheet.
MU600_00_016d_MB Obligations economic operators CH

Questions?

We are happy to support you as a Swiss representative in all matters. Contact us for an uncomplicated direct solution!

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