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IVDR - Regulation (EU) 2017/746

Thanks to the amendment to the IVDR adopted by the European Parliament and the Council in January 2022, the IVD Regulation can now be progressively rolled out.

Timeline_IVDR

The amending Regulation does not change any requirements of the original In Vitro Diagnostic (IVD) Regulation of 2017. It only changes transitional provisions.

No change is for CE-marked devices that do not require notified body involvement under the IVD Regulation (new „A“ class devices), or for new devices that will be placed on the market by 25 May 2022. For those, the IVD Regulation will therefore apply from 26th May 2022 as planned.

Our company has already utilized the opportunity of the transitional period and has got the IVDD CE certificates for all GeneProof PCR kits listed in Lists A and B valid until January 2024.

All of our „A“ class devices (instruments, NA extraction kits) will be certified according to IVDR from 27th May 2022.

GeneProof is completing all necessary documentation and testings for the technical files. We are not expected to reduce the number of CE IVD kits; contrariwise completing its STI and Respiratory lines and introducing of myCROBE lines.

GeneProof successfully continues on its way to IVDR certification across the whole product portfolio:

  • 25 products under various stages of review of NB
  • GeneProof SARS-CoV-2 IVDR PCR Kit – successfully undergone the expert panel review as the first kit detecting SARS-CoV-2 in EU
  • GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit – accepted for assessment