MEPs questioned EU Health Commissioner Stella Kyriakides about the risks of medical device shortages because the transition to a new framework for these products is not progressing smoothly.
Responding to an oral question to the Commission submitted by European lawmakers on the revision of the Medical Device Regulation (MDR), Kyriakides addressed concerns about implementation during the plenary session on Thursday (24 November) afternoon.
We are nearing the end of the transition period [May 2024]However, it became very clear that patient access to these devices was not guaranteed. “We are, in fact, facing a serious risk of a shortage of medical devices,” Kyriakides said.
Politicians and stakeholders have highlighted concerns about the implementation of the Medical Devices Regulation (MDR) review, which came into force in 2017 and came into force in May 2021. Now, MEPs are calling for swift action to implement it.
“Doctors, hospitals and producers of medical products sounded the alarm more than a year ago,” said MEP Angelica Niebler of the European People’s Party (EPP) and co-author of the oral question.
According to the oral question, one of the goals of the MDR review was to “address reported body system deficiencies and provide better controls for medical devices.”
“In practice, MDR leads to a decrease in the availability of medical devices across Europe. Consequently, patient care in the EU is getting worse rather than better,” the authors of the question wrote on behalf of the EPP.
In particular, delays in complying with the regulations, as well as the slow preparation of notified bodies to assess the conformity of these devices, are creating problems in obtaining certification for medical devices, with many devices disappearing from the market even though they used to be. In use for a long time.
Therefore, MEPs asked the committee what they intend to do to ensure medical devices remain available and to make changes to accreditation practices.
Kyriakides highlighted that significant progress has been made in implementing the new rules and that 34 notified bodies have been designated under the regulation, with their capacity significantly increased compared to previous rules.
It also noted the creation of new expert panels, which are “essential for a more comprehensive assessment of clinical data.”
The commissioner acknowledged calls for action, including calls to amend the bylaws to extend the transition period.
concerned members of the European Parliament
Back in August, the Medical Devices Coordination Group (MDCG) chaired by the European Commission approved a list of measures to facilitate the transition to the new framework for medical devices, after a warning from EU health ministers.
The warnings indicated problems for medical device developers in meeting implementation deadlines for the Master Medical Devices (MDR) and In Vitro Diagnostics (IVDR) Regulations, which came into effect in May 2021 and May 2022, respectively.
In response to a specific question posed by Nippler and the other co-author, another centre-right MEP Peter Lyse, Kyriakides stated that MDCG has set up a task force on orphan devices and that it will put forward proposals for solutions for health. Council in December on this issue.
“My goal is to address both the very short-term issues, but also the structural issues that have come up,” said Kyriakides.
However, MEPs expressed clear concern about development and the lack of action yet to avoid shortages.
We have to be ambitious and take big steps forward. We have to consider long-term solutions,” said Lisi, who also addressed the severe bureaucratic issues in obtaining certification for medical devices.
She urged the French centrist MEP Veronique Trellet-Lenoir to accept that “the implementation of this regulation is currently in danger”. “There are very few organizations that have been notified, but we also haven’t been able to put expectations into production and it’s very slow,” she said.
Kyriakides assured them that the challenges did indeed have a political priority for the commission as “data from the notified bodies and industries show that the situation is indeed very challenging”.
Only approximately 2,000 certificates have been issued under the MDR, while about 23,000 certificates will expire in May 2024, the Commissioner informed.
“We are fully aware that with most certificates expiring, the situation is expected to get worse. So we are very aware of the urgency,” said Kyriakides.
We are working on a legislative proposal in addition to other measures. And our job is to make sure that safe devices must remain a priority and remain accessible to patients and our health system.”
[Edited by Gerardo Fortuna/ Alice Taylor]