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GeneProof complies with IVDR

GeneProof complies with IVDR
GeneProof has smoothly transitioned to the new IVDR legislation as planned and expected.

As of 27 May 2022, the company's activities are fully compliant with Regulation (EU) 2017/746 of the European Parliament and of the Council, as amended.

We continue to offer and sell the whole portfolio of more than 80 CE IVD products under the new EU IVD rules.

All Class A products are now IVDR certified:

Get the new EC Declaration of Conformity and Instruction for Use on the appropriate product pages.

All other PCR kits (which were classified as other IVD devices according to the IVDD) are fully compliant with the REGULATION (EU) 2022/112 – (IVDR amendment of 01/2022) and are fully available.

Nevertheless, we successfully continue on our way to IVDR certification of „B“, „C“ and „D“ Class devices:

GP_infografika_IVDR_produkty_cista_08_2022_03_EN

You can count on GeneProof – today and in the future!

 

What does IVDR mean for laboratories?

Read our FAQ's!

Do you want to ask more? Do not hesitate to contact us on [obfuscate_1_|108|88|111|104|95|115|96|107|100|58|102|92|107|98|106|113|102|108|99|40|98|102|106].