At GenDx the quality and safety of our products and services has always been a key priority. This includes having the proper certificates in place for both the quality management system as well as for the GenDx products.

GenDx’ journey towards IVDR compliance

When the first news came in 2017 that the IVDR (In Vitro Diagnostic Regulation) would be implemented May 2022 there was no hesitation to become compliant and continue to meet the highest standards.  Especially since the main aim of IVDR is to better safeguard the quality and safety of products for the benefit of patients; which lies close to our hearts.

Preparation and Implementation: Overcoming challenges

Most of the GenDx products were already CE-marked under the IVDD (In Vitro Diagnostic Directive) when IVDR was introduced which is a good basis to start from. Upon joining GenDx in 2019, the quality assurance and regulatory affairs colleagues had already prepared for IVDR readiness with gap analysis between IVDD and IVDR and preliminary transition plans.

In the three years that followed that plan was extended and all teams were involved to discuss and align on how to implement the legislation to the GenDx processes in a way that would be compliant but also practical for the employees. Meanwhile, the work on the technical documentation for first product’s in line to become IVDR compliant started as well as the updating of standard operating procedures and protocols. Management’s commitment was crucial in enabling these projects with sufficient resources.

It turned out that the major challenges lay in understanding IVDR requirements, than get it implemented with the proper documentation and last but not least to get this in line with the evaluation criteria of the Notified Body. Fortunately, GenDx already had a good relationship with their notified body TUV SUD, and since GenDx was amongst the first companies to apply for IVDR there was enough time and opportunity to align both content as well as timelines.

Achieving milestones and future plans

Since may 2022 GenDx holds an IVDR certificate for the entire NGSgo reagent product portfolio for HLA typing. In addition also NGSengine (HLA typing analysis software) is CE marked under the IVDR as a stand alone device. The latter is an accomplishment that GenDx is particularly proud of since it was one of the first software devices that obtained this status despite the fact that software registration under IVDR turned out to be very challenging from both a procedural as well as a documentation perspective.

In the coming years also the GenDx chimerism product portfolio will be transitioned to be IVDR compliant and all new products will be designed to be compliant from the start. In addition obtaining the CE-mark under IVDR as one of the first companies in our field also enables GenDx to team up with pharmaceutical partners to collaborate in the field of CDX (companion diagnostics) with the aim to help additional patients in different medical fields.

by Erica Kremer PhD, Director Compliance

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