As the the new EU In Vitro Diagnostic Regulation entered into force, marking the start of the transition period, ARC Regulatory hosted representatives from the UK and Ireland precision medicine industry to assess the impact on companion diagnostic development.
This timely meeting in Dublin coincided with the recent publication of the final text of the new EU In Vitro Diagnostic Regulation in the Official Journal of the European Union (OJEU), along with the anticipated publication by the EMA (European Medicines Agency) of a draft Concept paper on medicinal product/ CDx co-development.
Seamus Kearney, CEO of ARC Regulatory, who led and hosted the Companion Diagnostics workshop, as part of a 1-day IVD Symposium, commented:
“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. 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 .”
Peter Kerr, VP of Companion Diagnostic Development at Almac Diagnostics, who attended the CDx workshop, said,
“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.
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.”
Sue Spencer, Global Service Director – Regulatory at UL, who led the general IVD workshop, added:
“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. 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.”
The European Medecine’s Agency anticipated time table for the development of guidance on medicinal product/ CDx co-development was estimated to be June/ July this year, but now estimated to be August/ September, we await the publication of a Draft Concept paper for public consultation.
For more information on the regulatory and clinical support available to the IVD and CDx industry, please visit www.arc-regulatory.co.uk
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