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The amendment to the EU IVDR has been published in the Official Journal of the European Union.

This removes the sell-off provision for IVD products, meaning that IVDs legally placed on the market under their IVDD certification can continue to be supplied to users indefinitely. This does not mean that new product can be placed on the market after expiry of the IVDD certificate.

To utilise this, products cannot undergo any significant changes.

Along with this change to the EU IVDR, the amendment brings additional transition arrangements for medical devices under the EU MDR.