New regulation raises questions for companion diagnostics

With the implementation of the new European Union In Vitro Diagnostic Regulation (EU IVDR) commencing, questions have been raised on companion diagnostic (CDx) development, which were assessed at a recent meeting held by ARC Regulatory.

The meeting in Dublin coincided with the publication of the final text on the EU IVDR in the Official Journal of the European Union (OJEU) as well as the publication of a draft concept paper on medicinal product/CDx co-development by the European Medicines Agency (EMA).

“The new IVDR marks a sea-change in the regulation of Companion Diagnostic devices in the European Union, therefore we wanted to provide an effective forum for the industry to communicate the new requirements,” said Seamus Kearney, CEO of ARC Regulatory, who led and hosted the Companion Diagnostics workshop. “Whilst it was highlighted throughout discussions that many areas remain unclear in the CDx area, it was clear that the bar had been raised significantly for demonstration of compliance with the new regulatory paradigm. It was also evident that all industry players in this exciting, and rapidly growing, area of medicine are seeking early sight of implementing acts, particularly in relation to Annex XIII for clinical performance, along with any positions adopted by the EMA.”

“ARC Regulatory’s recent meeting provided an excellent forum to discuss the impact of the new regulation. Companion Diagnostics will be classified under Class C in the new IVDR and so there will be both Notified Body and Competent Authority interactions for manufacturers to deal with in the future, which may be seen by some as additional hurdles,” added Peter Kerr, VP of Companion Diagnostic Development at Almac Diagnostics, who attended the CDx workshop. “It will be interesting to see how implementation of the new regulation develops over the transition period to 2022, however Almac Diagnostics see this as an opportunity to ensure our Global IVD Development processes stay aligned with, for example, the US and specifically that there is one clear EU regulatory pathway from development to market.”

Maria Orr, executive director and lead of Companion Diagnostics at AstraZeneca, who also attended the afternoon workshop, commented: “The new IVDR becoming law marks an important and progressive shift in the regulation of companion diagnostics in the EU. The meeting provided a valuable opportunity to hear about the new regulations and to discuss and review the implications.”

“Previously, under the IVD Directive, manufacturers were able to go to market without Notified Body oversight. The scope however of the new EU IVD Regulation will now apply to products that potentially have been on the market for many years,” explained Sue Spencer, global service director — Regulatory at UL, who led the general IVD workshop. “It is therefore critical that CDx developers engage with their Notified Body early, to identify requirements and agree schedules that will ensure delivery within the transition period. UL welcome those conversations now, as it will facilitate resource planning and getting to know the specifics of the company and product line.”