Health commissioner quizzed on curbing medical device shortage - EURACTIV

2 years ago 40

MEPs questioned EU Health Commissioner Stella Kyriakides astir the hazard of aesculapian instrumentality shortages arsenic the modulation into a caller model for these products is not progressing smoothly.

In effect to an oral question to the Commission filed by European lawmakers astir the revision of the Medical Devices Regulation (MDR), Kyriakides addressed concerns astir the implementation during the plenary session Thursday day (24 November).

“As we determination towards the extremity of the modulation play [May 2024], it has go highly wide that ensuring diligent entree to these devices is not guaranteed. We are, successful fact, facing a superior hazard of shortages of aesculapian devices,” Kyriakides said.

Concerns astir the implementation of the revision of the Medical Devices Regulation (MDR), which entered into unit backmost successful 2017 and into exertion successful May 2021, person been highlighted by some politicians and stakeholders. Now, the MEPs are calling for swift enactment connected its implementation.

“Doctors, hospitals, and producers of aesculapian products person been sounding the alarm for implicit 1 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, 1 of the goals of the revision of the MDR was to “address deficiencies successful the notified assemblage strategy and supply amended controls for aesculapian devices.”

“In practice, the MDR is starring to a alteration successful the availability of aesculapian devices crossed Europe. Consequently, diligent attraction successful the EU is worsening alternatively of improving,” the authors of the question wrote connected behalf of the EPP.

In particular, delays successful complying with the regulations, arsenic good arsenic the dilatory set-up of the notified bodies to measure the conformity of these devices, are creating problems with obtaining certification for aesculapian devices, with galore devices disappearing from the marketplace contempt having been successful usage for a agelong time.

Therefore, the MEPs asked the Commission what they mean to bash to guarantee aesculapian devices stay disposable and that changes are made to the certification practices.

Kyriakides highlighted that overmuch advancement had been made successful implementing the caller rules and that 34 notified bodies had been designated nether the regulation, with their capableness importantly accrued compared to erstwhile rules.

She besides mentioned mounting up caller adept panels, which are “essential for the much thorough appraisal of objective data.”

The Commissioner acknowledged the calls for action, including the calls for an amendment to the regularisation to widen the modulation period.

MEPs concerned

Back successful August, the Medical Device Coordination Group (MDCG) chaired by the European Commission approved a database of actions to easiness the modulation into the caller model for aesculapian devices, pursuing a informing from EU wellness ministers.

The warnings cited troubles for developers of aesculapian devices successful gathering the deadlines for implementing cardinal regulations for aesculapian devices (MDR) and successful vitro diagnostics (IVDR), which entered into exertion connected May 2021 and May 2022, respectively.

Addressing a circumstantial question posed by Niebler and the different co-author, the different German centre-right MEP Peter Liese, Kyriakides mentioned that the MDCG has acceptable up a task unit connected orphan devices and that she would bring distant proposals for solutions to the wellness assembly successful December connected the issue.

“My nonsubjective is to code some the precise short-term issues, but besides the structural issues that person appeared,” Kyriakides said.

However, MEPs expressed wide interest implicit the improvement and the deficiency of enactment taken truthful acold to debar the shortages.

“We person to beryllium ambitious and instrumentality large steps forward. We person to instrumentality into information the semipermanent solutions,” said Liese, who besides addressed issues with dense bureaucracy successful obtaining certification for aesculapian devices.

Centrist French MEP Veronique Trillet-Lenoir, urged for acceptance that “the implementation of this regularisation is presently successful danger.” “There are excessively fewer notified organisations, but we person besides been incapable to enactment forecasts successful accumulation and it is excessively slow,” she said.

Kyriakides ensured them that the challenges bash so person governmental precedence for the Commission arsenic “the information received from the notified bodies and manufacture amusement that the concern is so highly challenging.”

Only astir 2000 certificates person been issued nether the MDR, portion astir 23,000 volition beryllium expiring successful May 2024, informed the Commissioner.

“We afloat recognise that arsenic astir certificates expire, the worse the concern is expected to become. So we’re precise conscious astir the urgency,” Kyriakides said.

“We’re moving connected legislative connection positive different actions. Our task is to guarantee that harmless devices request to stay a precedence and stay disposable for patients and for our wellness system,” she concluded.