EU lawmakers questioned EU Health Commissioner Stella Kyriakides about the risk of medical device shortages as the transition into a new framework for these products is not progressing smoothly.
In response to an oral question to the Commission filed by European lawmakers about the revision of the Medical Devices Regulation (MDR), Kyriakides addressed concerns about the implementation during the plenary session Thursday afternoon (24 November).
“As we move towards the end of the transition period [May 2024], it has become extremely clear that ensuring patient access to these devices is not guaranteed. We are, in fact, facing a serious risk of shortages of medical devices,” Kyriakides said.
Concerns about the implementation of the revision of the Medical Devices Regulation (MDR), which entered into force back in 2017 and into application in May 2021, have been highlighted by both politicians and stakeholders. Now, the MEPs are calling for swift action on its implementation.
“Doctors, hospitals, and producers of medical products have been sounding the alarm for over one year,” said MEP Angelika Niebler from the centre-right European People’s Party (EPP) and co-author of the oral question.
According to the oral question, one of the goals of the revision of the MDR was to “address deficiencies in the notified body system and provide better controls for medical devices.”
“In practice, the MDR is leading to a decrease in the availability of medical devices across Europe. Consequently, patient care in the EU is worsening instead of improving,” the authors of the question wrote on behalf of the EPP.
In particular, delays in complying with the regulations, as well as the slow set-up of the notified bodies to assess the conformity of these devices, are creating problems with obtaining certification for medical devices, with many devices disappearing from the market despite having been in use for a long time.
Therefore, the MEPs asked the Commission what they intend to do to ensure medical devices remain available and that changes are made to the certification practices.
Kyriakides highlighted that much progress had been made in implementing the new rules and that 34 notified bodies had been designated under the regulation, with their capacity significantly increased compared to previous rules.
She also mentioned setting up new expert panels, which are “essential for the more thorough assessment of clinical data.”
The Commissioner acknowledged the calls for action, including the calls for an amendment to the regulation to extend the transition period.
MEPs concerned
Back in August, the Medical Device Coordination Group (MDCG) chaired by the European Commission approved a list of actions to ease the transition into the new framework for medical devices, following a warning from EU health ministers.
The warnings cited troubles for developers of medical devices in meeting the deadlines for implementing key regulations for medical devices (MDR) and in vitro diagnostics (IVDR), which entered into application on May 2021 and May 2022, respectively.
Addressing a specific question posed by Niebler and the other co-author, the other German centre-right MEP Peter Liese, Kyriakides mentioned that the MDCG has set up a task force on orphan devices and that she would bring forth proposals for solutions to the health council in December on the issue.
“My objective is to address both the very short-term issues, but also the structural issues that have appeared,” Kyriakides said.
However, MEPs expressed clear concern over the development and the lack of action taken so far to avoid the shortages.
“We have to be ambitious and take major steps forward. We have to take into consideration the long-term solutions,” said Liese, who also addressed issues with heavy bureaucracy in obtaining certification for medical devices.
Centrist French MEP Veronique Trillet-Lenoir, urged for acceptance that “the implementation of this regulation is currently in danger.” “There are too few notified organisations, but we have also been unable to put forecasts in production and it is too slow,” she said.
Kyriakides ensured them that the challenges do indeed have political priority for the Commission as “the data received from the notified bodies and industry show that the situation is indeed extremely challenging.”
Only approximately 2000 certificates have been issued under the MDR, while about 23,000 will be expiring in May 2024, informed the Commissioner.
“We fully recognise that as most certificates expire, the worse the situation is expected to become. So we’re very conscious about the urgency,” Kyriakides said.
“We’re working on legislative proposal plus other actions. Our task is to ensure that safe devices need to remain a priority and remain available for patients and for our health system,” she concluded.
[Edited by Gerardo Fortuna/ Alice Taylor]
