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European Council confirms they will not amend IVDR delay proposal

By December 3, 2021No Comments

On 1st December, the European Council confirmed that they have agreed to proceed with an accelerated legislative procedure for the proposed delay of the EU IVDR. This means they will not be suggesting any changes to the text included with the proposal in order for it to progress through legislation more quickly than would typically take.

This proposal pushes back the full implementation of the EU IVDR based on the risk class of the IVD, primarily due to the lack of notified bodies designated. These timelines would bring implementation to the following dates:

• 26 May 2025 for class D devices
• 26 May 2026 for class C devices
• 26 May 2027 for class B devices, and class A devices placed on the market sterile

Products placed on the market pursuant to transitional periods under IVDD certificates have also been extended by 1 year to 26 May 2025.

There are some caveats to this proposal, and we recommend you familiarise yourself with the requirements to understand when your products would be expected to comply.

The proposal will now be reviewed the European Parliament on the 6th and 7th of December.