IVDR Impact on Companion Diagnostics

Mi3 News

Companion diagnostics (CDx) are classed as in vitro diagnostics (IVDs) and they increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes and decrease costs by ruling out therapies that are less likely to be effective.

CDx are typically developed in close collaboration with drug development companies and can help to predict positive and negative responses based on the personal characteristics of each individual patient before being prescribed with a chosen therapy1, 2.

Therefore, pharmaceutical manufacturers are subject to regulatory oversight for both the device and medicinal parts of combination products, including CDx (which falls under IVDR in the EU), and must have Notified Body (NB) involvement for the ancillary device component, while the diagnostic device is developed with the target medicine3.

The IVDR will come into force in this May 2022, and in it, a change of regulation of CDx devices in the EU including the requirement for a performance evaluation with significant evidence of clinical performance and the change in classification for CDx assays from a General IVD to a class C (second highest risk) device4. The IVDR defines and regulates CDx as distinct devices with subsequent requirement for greater NB involvement. Article 2(7) of the IVDR states that “‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to “(a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) identify before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product”4, 5.

Regulation of CDx will require a summary of safety and performance and a full Quality Management System with technical file review of at least one device per generic group (Annex IX) or EC type-exam (Annex X) with production quality assurance or EC verification (Annex XI)4,5.  The IVDR is not greatly different from the IVDD but there are some significant changes. However, very little of what is required by the IVDR is completely new; most of the new requirements are extensions to already existing requirements. In most cases the new requirements simply bring the EU regulations up to date and into line with the regulatory requirements for IVDs in the rest of the world, a comparison of the requirements of IVDD v IVDR is shown overleaf.6

Given the cost of additional studies required to support compliance, this may lead to some low-margin/low-volume diagnostic tests being withdrawn from the EU market as it will likely be uneconomic to pass them through the revised regulatory approval. In addition, with growing trends toward stricter regulatory enforcement for IVD testing and quality, manufacturers face greater pressure to bring products to market quickly, while balancing the regulatory environment2.



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