BREAKING NEWS - Amendment to the IVDR transitional arrangements adopted

Sue Spencer "The new In Vitro Diagnostics Regulation (IVDR) transitional arrangements have been published to the great relief of all stakeholders. There is a lot to consider, but as we said before it is really important, don’t take your foot off the gas! There is still a lot of work to do."

I am delighted to tell you that the proposal to amend the transitional arrangements of the IVDR and defer the application of some of the in-house requirements has been adopted.

 This is the best Christmas present for the IVD sector but remember this is not a delay!

  • Class A devices, new devices must still meet the 26 May 2022 date
  • PMS and vigilance still apply 26 May 2022
  • Performance evaluation requirements will apply from 26 May 2022
  • No significant changes can be made to existing devices, so you need to wrap your head around what is a significant change!

The road to IVDR implementation is going to be a long one but we will be there to support you.

From everyone at Qserve enjoy your holidays but when it comes to IVDR implementation "Don't take your foot off the gas!". You may find our Snakes and Ladders Webinar useful for more detail.


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