What is the “sell off” provision?

The “sell off” provision (art. 110 par. 4 IVDR) is intended to limit the time during which IVDD conform devices, already placed on the market, can be made available, for example, by a Distributor.

After May 27, 2025 these devices may not be available/put into service. If such devices are still within the supply chain by this date, they are no longer considered marketable devices.

In the first place, this provision is therefore responsible for the “making available” of conform IVDD devices once they are on the market, but it does not apply to second-hand sales. Therefore, once the device is made available for the final user (e.g. the hospital) as ready for use, this device is subject / covered by the IVDR.

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