European Council members support proposal to delay MDR deadlines

"European Council members expressed support for a proposal by the European Commission to delay the transitional deadlines for medical devices under the Medical Devices Regulation (MDR). Members said they are concerned there isn’t enough capacity to handle all the thousands of outstanding conformity assessments that must be completed before the transitional period provided in Article 120(3) of the regulation expires and fear the current deadlines could trigger widespread shortages if left in place.

Stella Kyriakides, the European health commissioner, proposed postponing the MDR transitional deadlines during a 9 December session of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in Brussels. She urged the Council and the European Parliament to extend the deadline for higher risk class III and class IIb devices to 2027 and the deadline for lower risk class I and class IIa devices to 2028.

“The transition to the new rules has been slower than we anticipated,” she said. “The pandemic, shortages of raw materials caused by the Russian invasion against Ukraine and low notified body capacity has put a strain on market readiness.”

Kyriakides noted that there has been recent progress toward the new framework, including an increase in the number of notified bodies designated for medical devices from 30 in June 2022 to 36. The number of notified bodies designated under IVDR currently stands at eight.

The European Commission’s Medical Device Coordination Group (MDCG) has also recently proposed measures to increase notified body capacity and preparedness. (RELATED: MDCG encourages hybrid audits, other actions to improve notified body capacity, Regulatory Focus 29 August 2022)

Despite those efforts, Kyriakides warned that around 23,000 devices and 1,500 IVDs certified under the previous directive have not yet transitioned to the new regulation and are likely to expire in May 2024 and May 2025, respectively. She added that she’s heard from national experts, members of the European Parliament and other stakeholders who are worried about products being taken off the European market if nothing is done.

“We are facing a risk of shortages of life-saving medical devices for patients. This is a risk that we cannot take,” said Kyriakides. “I therefore propose to you today that we extend the transition period of the regulation to mitigate any short-term risk. This targeted amendment would include staggered deadlines depending on the risk of each device.”

She also said the extensions should also be subject to certain conditions to ensure they apply only to devices that do not present any unacceptable risk to health and safety. Those devices should also not have undergone significant changes in design or intended purpose and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR..." Lire la suite