GeneProof complies with IVDR

GeneProof is among the first European IVD manufacturers to fully comply with the in vitro Diagnostic Regulation (IVDR)

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.

Our entire portfolio of more than 80 CE IVD products are available under the new EU IVD rules.

All Class A products are now IVDR certified:

• croBEE^® max Nucleic Acid Extraction Kit
• croBEE^® 201A Nucleic Acid Extraction Kit
• GeneProof PathogenFree DNA Isolation Kit
• GeneProof PathogenFree RNA Isolation Kit
• croBEE^® NA16 Nucleic Acid Extraction System Plus
• croBEE^® 2.0 Nucleic Acid Extraction System
• croBEE^® Real-Time PCR System
• myCROBE^® Fully Automated Instrument
• myCROBE^® / croBEE^® 2.0 Universal Extraction Kit
• myCROBE^® / croBEE^® 2.0 Blood Pretreatment Sample tube
• myCROBE^® / croBEE^® 2.0 Urine Pretreatment Sample tube

Get the new EC Declaration of Conformity and Instruction for Use are available on our 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 our D Class devices:

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|110|103|98|115|96|106|99|61|102|92|106|97|109|113|102|107|98|43|98|102|105].