GENERI BIOTECH successfully completed recertification after moving the company to new production facilities

We are very pleased to announce that GENERI BIOTECH has entered August as a fully re-certified company.

This has been a very busy period. It was only at the end of April when we completed moving of our entire manufacturing facilities, and in just three months we have implemented new manufacturing technologies and successfully passed all four recertification audits. Thank you and congratulations to all our employees who have contributed to the company’s excellent preparedness!

The transition of the company was extremely challenging and took place in a very short period of time. Our goal was to ensure the shortest possible disruption in the delivery of our products and services to the market. This move required careful planning and coordination (however, as is often the case with relocations, things don’t always go as planned) to minimize the impact on our customers and partners.

Although we have now completed all audits and we can fully resume our production and services, the process of approving such a significant change is not just about passing the audits. We now also have to wait for all updated certificates to be documented, which will take up to several months. This period requires patience and careful monitoring of every step to ensure that all our products meet the highest quality and safety standards. At this moment, we have already updated certificates for ISO 9001 and GxP.  The remaining certificates under ISO 13485 and certification in accordance with EU Regulation 746/2017 (IVDR) are now going through the Notified Body approval process and we expect to receive the new certificates in autumn 2024.

Nevertheless, we at GENERI BIOTECH are not waiting for anything, we are still supplying IVD devices to the market that were originally certified under the IVDD. At the same time, we are already preparing our stock of products in accordance with Regulation 746/2017 (IVDR) and as soon as we receive all necessary certificates, we will start selling our products under this regulation. Therefore, we are continuously working to ensure that everything is ready to start IVDR production and distribution at the earliest.

Moreover, we are working with our business partners and distributors on the update of the registrations of our products in their countries (updating technical documentation). This cooperation is crucial to ensure the continuous supply of our IVD devices to customers worldwide without unnecessary delays.

We would like to thank all those involved in this demanding process, we thank all our business partners and clinical laboratories for their support during this very challenging period and we look forward to our further cooperation.