MEPs quizzed EU Health Commissioner Stella Kyriakides on the risk of medical device shortages as the transition to a new framework for such products is not progressing smoothly.
In response to an oral question to the Commission tabled by EU lawmakers on the review of the Medical Devices Regulation (MDR), Kyriakides raised concerns about the implementation during Thursday afternoon’s plenary session ( November 24).
“As we approach the end of the transition period [May 2024], it has become overwhelmingly clear that patient access to these devices is not guaranteed. We are in fact facing a serious risk of medical device shortages,” Kyriakides said.
Concerns about the implementation of the review of the Medical Devices Regulation (MDR), which entered into force in 2017 and came into force in May 2021, have been highlighted by both politicians and stakeholders. Now, MEPs are calling for rapid action on its implementation.
“Doctors, hospitals and manufacturers of medical products have been sounding the alarm for over a year,” said MEP Angelika Niebler of the centre-right European People’s Party (EPP) and co-author of the question. oral.
According to the oral question, one of the aims of the MDR revision was to “address deficiencies in the notified body system and provide better controls for medical devices”.
“In practice, the MDR leads to a decrease in the availability of medical devices across Europe. As a result, patient care in the EU is deteriorating rather than improving,” the authors of the question wrote on behalf of the EPP.
In particular, delays in compliance with regulations, as well as the slowness of setting up notified bodies to assess the conformity of these devices, create problems in obtaining certification for medical devices, many devices disappearing from the market when they had been in use for a long time.
MEPs therefore asked the Commission what they intend to do to ensure that medical devices remain available and that changes are made to certification practices.
Kyriakides pointed out that considerable progress has been made in implementing the new rules and that 34 notified bodies have been appointed under the regulation, with their capacity having increased considerably compared to the previous rules.
She also mentioned the establishment of new expert groups, which are “essential for further evaluation of clinical data”.
The commissioner acknowledged the calls for action, including calls for a rule change to extend the transition period.
Last August, the Medical Devices Coordination Group (MDCG) chaired by the European Commission endorsed a list of actions to facilitate the transition to the new framework for medical devices, following a warning from Ministers of EU health.
The warnings cite difficulties for medical device developers to meet deadlines for implementing key regulations for medical devices (MDR) and in vitro diagnostics (IVDR), which came into force in May 2021 and May 2022, respectively.
Responding to a specific question posed by Niebler and the other co-author, fellow centre-right German MEP Peter Liese, Kyriakides mentioned that the MDCG has set up a working group on orphan devices and that it would present proposals for solutions to the December health council on the issue.
“My aim is to address both the very short-term issues, but also the structural issues that have emerged,” Kyriakides said.
However, MEPs expressed concern about the development and the lack of measures taken so far to avoid shortages.
“We have to be ambitious and take big steps forward. We have to consider the long-term solutions,” said Liese, who also addressed issues related to heavy bureaucracy in obtaining certification for medical devices.
Centrist French MEP Véronique Trillet-Lenoir, urged to accept that “the implementation of this regulation is currently in danger”. “There are too few notified bodies, but we haven’t been able to put forecasts into production either and it’s been too slow,” she said.
Kyriakides assured them that the challenges were indeed a political priority for the Commission as “the data received from notified bodies and industry shows that the situation is indeed extremely difficult”.
Only around 2,000 certificates have been issued under the MDR, while around 23,000 will expire in May 2024, the commissioner said.
“We fully recognize that the longer most certificates expire, the worse the situation is expected to get, so we are very aware of the urgency,” Kyriakides said.
“We are working on a legislative proposal as well as other actions. Our task is to ensure that safe devices remain a priority and remain available for patients and for our healthcare system,” she concluded.
[Edited by Gerardo Fortuna/ Alice Taylor]
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