Quality Assurance and Certification

GeneProof complies with IVD Regulation (EU) 2017/746

As of 27 May 2022, GeneProof’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.  See more details.

EU Quality Management System Certificate

GeneProof successfully passed all necessary audits in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council. These audits confirm that the GeneProof management system is fully aligned to the standard and is fully operational within the organization.

The EU Quality Management System Certificate was issued by the notified body BSI Group The Netherlands B.V. (NB 2797) on 11^th January 2023. This makes GeneProof one of the first companies in Europe, that has achieved this challenging milestone.

Quality Management System Certificate according to ISO 13485

The Quality Management System of GeneProof a.s. is certified according to ČSN EN ISO 13485 ed. 2:2016. The certification applies to the design, development, manufacturing, and sales of in vitro diagnostic medical devices.

EC Certificate – Full Quality Assurance System

The quality of the manufacturer GeneProof a.s. has been certified as meeting the requirements of Directive 98/79/EC of in vitro diagnostic for the following products:

• GeneProof Hepatitis B Virus (HBV) PCR Kit
• GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit
• GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit
• GeneProof HIV type 1 (HIV-1) PCR Kit
• GeneProof Cytomegalovirus (CMV) PCR Kit
• GeneProof Cytomegalovirus (CMV) MC PCR Kit
• GeneProof Chlamydia trachomatis PCR Kit
• GeneProof Chlamydia trachomatis MC PCR Kit
• GeneProof Chlamydia pneumoniae PCR Kit
• GeneProof CT/NG/MG Multiplex PCR Kit

The Notified Body No 1023 has declared that GeneProof a.s. has implemented a quality assurance system for the design, manufacture, and final inspection of the respective devices in accordance with IVDD Annex IV. This quality assurance system conforms to the requirements of Directive 98/79/EC and is subjected to periodical surveillance.

EC Design-Examination Certificate

The Notified Body No. 1023 has performed an examination of the design dossier relating to devices in accordance with IVDD Annex IV. The design of the devices stated below conforms to the requirements of this Directive.

• GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit
• GeneProof Hepatitis B Virus (HBV) PCR Kit
• GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit
• GeneProof HIV type 1 (HIV-1) PCR Kit

EQA Panels

All GeneProof products are regularly tested in External Quality Assessment Panels of QCMD and Instand e.V. For detailed information see the product page. 

Regulatory Affairs

We provide full support to our partners in the area of Regulatory affairs in the countries of operation. We closely cooperate with our distributors and prepare the registration documentation based on specific legislative requirements of National Authorities.  

IVDR - Regulation (EU) 2017/746 of the European Parliament and the Council

GeneProof a.s. sees the new regulation as a really big opportunity. 

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 2024.

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.

IVDR is the top priority of the GP management and entire staff.

Other Certificates

The Company takes care of recycling packaging materials from the purchased base materials and it participates in assuring returning and recycling of packaging waste organized by the EKO-KOM company under the identification number EK-F00041495. Disposal of potentially infectious waste is organized by an external supplier.