Published: Tue, 29 November 2022
A patient’s access to vital medical technologies should be safeguarded by introducing targeted flexibilities to the EU Medical Device Regulation (MDR) as “a matter of life and death for Irish and European patients”, warned Seán Kelly MEP and leader of Fine Gael in the European Parliament. The Ireland South MEP has expressed concerns ahead of an urgent May 2024 deadline to certify vital medical products before they are discontinued.
“Medical technologies, such as cardiac pacemakers, insulin pumps, or in vitro diagnostics, are essential to maintaining and restoring patient health. They are also integral tools for healthcare professionals to provide the care to patients that they need,” the Ireland South MEP said.
In 2017, the Medical Devices Regulation (MDR) was revised with the goal of enhancing patient safety with more stringent EU-wide safety and performance requirements for medical technology.
“While revision of the MDR was done with the important objective of improving patient safety and treatment options, difficulty with its implementation is having the opposite effect. A shortage in notified bodies, the designated bodies for certifying medical devices under the MDR, has created a backlog. Due to this certification backlog, by May 2024, there is a risk that one-in-four medtech products currently in use could be discontinued. The reason being that all medical devices must be certified under the new Regulation by May 2024 at the latest.
“We must take a pragmatic and responsible approach to address these certification bottlenecks”, Kelly urged.
“I am calling on the European Commission to introduce targeted flexibilities in the implementation of this Regulation to ensure that these bottlenecks are addressed. We cannot lose essential healthcare products, of excellent quality, because of bureaucratic inefficiencies.”
This outcome is entirely at odds with the logic of the 2017 MDR Revision, according to MEP Kelly.
The MDR poses risks to European innovation and competitiveness: “At a time when Europe should be building up home-grown industry and investing in innovation, without targeted adjustments to the implementation of this Regulation, we risk losing medtech firms to the US and other markets outside the EU.”
Ireland is a hub for the medtech industry within Europe, as the second largest exporter of medical technologies and greatest employer of medtech professionals per capita.
“As my colleagues highlighted in a letter to the Commission President Ursula Von der Leyen in July, the MDR is weakening the healthcare system, not improving it. This is simply not good enough.
“This is an issue that my Fine Gael colleagues and I, in particular Deirdre Clune MEP, have been raising in Parliament for quite some time. We will continue to advocate in the interest of Irish patients and healthcare workers” Kelly concluded.