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Cancer Q2 2022

New EU regulation must ensure patient access to diagnostics

iStock / Getty Images Plus / megaflopp

Sinead Keogh

Director, Irish MedTech Associaiton, Ibec

In vitro diagnostics (IVDs) help tackle cancer by informing clinical decision making and treatment, with IVDs manufactured in Ireland making an impact globally.

Cancer is the leading cause of death in Ireland accounting for nearly one in three deaths. Innovation in medical technologies and healthcare have improved opportunities for better outcomes with earlier diagnoses, better monitoring and treatment.  

Nearly 200,000 people who were or had been cancer patients were still alive in Ireland according to some of the latest research in 2019. But survival rates vary.

To address this challenge the HSE’s National Cancer Control Programme is striving to create the conditions for greater prevention, diagnosis and treatment, to increase survival and improve quality of life. The medtech industry and its in vitro diagnostics (IVD) manufacturers make a very important contribution in driving this change.

Early diagnosis is key to better patient outcomes

IVDs are non-invasive, test tube, tests used to determine a person’s health status and are an essential part of any health system. They enable early diagnosis of cancer, ongoing screening and crucially, clinical decision-making.

IVDs are an integral part of patient pathways, with an estimated 70% of clinical decisions informed by IVDs, reducing the risk of ineffective treatment and increasing personalised care.

Effective EU regulations are essential for patients

To be placed onto the market and qualify for use within health systems, a very high regulatory bar is set for IVDs to demonstrate safety, efficacy and clinical benefit. Those products which meet this threshold are awarded a CE mark.

IVDs are an integral part of patient pathways, with an estimated 70% of clinical decisions informed by IVDs.

From the 26th May 2022, the EU Directive for IVDs will be replaced by a more stringent regulatory regime under the EU IVD Regulation. This will see diagnostics such as cancer assays subject to more rigorous, risk-based assessments.

IVD manufacturers support the new EU IVD Regulation which should deliver a predictable, innovation centric regulatory regime which will benefit healthcare systems and patients alike across the EU.

Delivering value for patients and health care systems

Use of IVDs contributes to reduced hospital stays for Irish cancer patients and a healthier population. Ultimately it also contributes to the Irish economy through healthcare system savings and employment of scientists and professionals across IVD industry, including in high-end IVD R&D.

Innovative cancer diagnostic assays developed and manufactured in Ireland are exported to far-reaching global markets contributing to positive healthcare outcomes for cancer patients far beyond our shores.  

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