Health commissioner questioned to curb medical equipment shortage –

MEPs questioned EU Health Commissioner Stella Kyriakides about the risk of medical device shortages as the transition to a new framework for these products is not progressing smoothly.

In response to an oral question from the Commission filed by European lawmakers about the revision of the Medical Device Regulation (MDR), Kyriakides addressed concerns about implementation during a plenary session on Thursday afternoon (24 November).

“As we approach the end of the transition period [May 2024], it has become abundantly clear that ensuring patient access to these devices is not guaranteed. In fact, we are facing a serious threat of shortage of medical equipment,” Kyriakides said.

Concerns about the implementation of the amendment to the Medical Device Regulation (MDR), which came into force back in 2017 and are due to come into force in May 2021, have been highlighted by both politicians and stakeholders. Now, MEPs are demanding quick action on its implementation.

“Physicians, hospitals and manufacturers of medical products have been sounding the alarm for more than a year,” said Angelica Nibler, MEP 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 “remove deficiencies in the notified body system and provide better controls for medical devices”.

“In practice, MDR is reducing the availability of medical equipment 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 slow establishment of notified bodies to assess the conformity of these devices, are causing problems in obtaining certification for medical devices, with many devices disappearing from the market despite are happening in use for a long time.

Therefore, MEPs asked the Commission what they intend to do to ensure that medical devices remain available and that changes are made to certification practices.

Kyriakides highlighted that great progress has been made in implementing the new regulations and that 34 Notified Bodies have been designated under the regulation, with their capacity significantly increased compared to previous regulations.

He also mentioned setting up new expert panels, which are “needed for a more thorough evaluation of clinical data.”

The commissioner acknowledged calls for action, including calls for amendments to the regulation to extend the transition period.

MEP related

Back in August, the Medical Devices Coordination Group (MDCG), chaired by the European Commission, approved a list of actions to ease the transition to the new framework for medical devices, following warnings from EU health ministers.

The warnings cited difficulties for developers of medical devices in meeting the deadlines for implementing the key regulations for medical devices (MDR) and in vitro diagnostics (IVDR), which came into effect on May 2021 and May 2022, respectively.

Addressing a specific question asked by Niebler and other co-authors, another German centre-right MEP Peter Lise, Kyriakides noted that the MDCG has formed a task force on orphan devices and that it is working on a solution for health Will make an offer. Council in December on this issue.

Kyriakides said, “My aim is to address both very short-term issues, but also to reveal structural issues.”

However, MEPs expressed clear concern over the lack of action taken so far to avoid growth and shortages.

“We have to be ambitious and take big steps forward. We have to consider long-term solutions,” said Lise, who also addressed issues of heavy bureaucracy in obtaining certification for medical devices.

Centrist French MEP Véronique Trillet-Lenoir urged for approval that “the implementation of this regulation is currently under threat.” “There are very few notified organisations, but we are also unable to forecast production and it is very slow,” she said.

Kyriakides assured him that the challenges are indeed a political priority for the Commission because “data from notified bodies and industry show that the situation is indeed extremely challenging.”

Only about 2000 certificates have been issued under the MDR, while about 23,000 are expiring in May 2024, the commissioner informed.

“We fully recognize that as most certifications expire, the situation has the potential to worsen. So we are very conscious of the urgency,” Kyriakides said.

“We are working on the legislative proposal and other actions. Our job is to ensure that the safe equipment needed remains a priority and available to patients and our health system,” she concluded.

[Edited by Gerardo Fortuna/ Alice Taylor]

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