With the recent application of IVDR on May 26, 2022, there are new regulatory standards that oversee the sales and use of IVDs for the EU. As with any new regulation, there’s been a scramble to properly interpret the impact of IVDR on clinical trials and the use of established and novel laboratory testing. Drawing from our internal regulatory and quality subject matter experts alongside regulatory consultants, we’ve developed a framework to partner with our sponsors to support IVDR obligations.
Roles and Responsibilities...
A common question we hear relates to the roles and responsibilities with regards to IVDR submissions. The sponsor of the clinical trial holds responsibility for IVDR-related submissions. NeoGenomics supports by providing relevant device or assay specific information that are part of the Sponsor’s regulatory dossier (i.e. clinical trial application).
When does IVDR come into play?
In the decision tree outlined in the figure below that helps in clarifying this question. Simply stated, IVDR compliance needs to be considered whenever samples originate from the EU or testing occurs on EU patient samples. Importantly, this is irrespective of the country where the testing laboratory is located. For example, if testing occurs in a US-based laboratory for a clinical trial occurring in the EU, IVDR needs to be considered.
If EU samples are tested, next on the decision tree is to assess the “intended use” of the biomarker results to clearly understand whether the biomarker results have a “medical purpose”. Clarity on whether results have a medical purpose is key to determining if the assay needs to comply with IVDR. As this is a fundamental point, a follow up blog post will be dedicated to expand on this topic.
Also key to compliance with IVDR is whether CE-IVD marked reagents/kits/devices are being used, and furthermore, per their approved instructions for use. If yes, then no additional submissions required. However, if using a fit for purpose assay (i.e. “LDT”; clinical trial assay) or a CE-IVD kit off label, then submission is required on the performance of the device.
This is the first in a series of IVDR focused blogs touching upon IVDR education and awareness. This series provides an educational tool intended as a primer to IVDR & related topics, sharing our team’s thoughts on the topic, and (hopefully) help clarify thinking for the reader.