European Council members support proposal to delay MDR deadlines

Regulatory NewsRegulatory News | 09 December 2022 |  By 

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.
 
Kyriakides also recommended removing the “sell off” date of May 2025 under both MDR and the In Vitro Diagnostic Devices Regulation (IVDR) to prevent safe medical devices which are already on the market from being discarded. If the members agree, she said the amendment will be presented to them in January when Sweden takes leadership of the council.
 
“I believe that this targeted amendment would allow us to address the short-term difficulties we face,” Kyriakides said. “I also believe that this must be accompanied by additional measures to address the structural problems of the regulation we are now seeing.”
 
Kyriakides said the council should consider prioritizing orphan devices staying on the market so patients can continue to access them.
 
“We must also shape a regulatory environment that fosters innovation and ensures that notified bodies are enabled to focus on the key tasks at hand, patient safety and less bureaucracy,” she added. “In order to promote innovation, a pilot project will be launched early next year to offer scientific advice from expert panels on medical devices to manufacturers. This will be targeted to manufacturers of orphan and breakthrough devices, and more support to (small- and mid-sized enterprises) is also something we'll be working on. 
 
The council members overwhelmingly supported the proposal to extend the deadlines as proposed by Kyriakides. The representative from Malta went a step further and proposed extending the deadline for all products to 2028 to avoid any confusion.
 
Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD and a RAPS board member; and Gert Bos, CEO of Qserve and president of RAPS’ board of directors; are cautiously optimistic about Kyriakides proposal.
 
“For MDR, this might be sufficient to get us to a better place for the availability of devices,” they told Focus. “For IVDR, the current already extended deadlines might not be sufficient, so an additional delay cannot be excluded.” (RELATED: IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage, Regulatory Focus 14 October 2021; IVDR’s progressive rollout gets official with EU Council, Parliament adoption, Regulatory Focus 20 December 2021)
 
They noted that the reference labs needed for class D products are still not set up and that it would have been more efficient if IVDR transition timelines were better addressed in the current proposal. Instead, they anticipate another proposal on the matter toward the end of 2023.
 
Hoekstra-van den Bosch and Bos also said that manufacturers who have already transitioned their products to MDR will more easily be able to implement any necessary regulatory changes in the future and can focus on improving their products. They will also have an easier time exporting their products. The experts note that some hospitals are already asking for MDR certification when buying products.
 
“On the other hand, manufacturers that still market their products under the directives might benefit as they could postpone the additional costs related to transfer to the regulations,” they added.
 
Hoekstra-van den Bosch and Bos are also concerned that two new deadlines may create waves of workload for notified bodies as they get closer to the new deadlines.
 
“This will then continue every 5 years in the future,” they added. “Also, some classification discussions, especially in the field of software, could be enhanced as the risk classification now determines the deadline.”
 
Hoekstra-van den Bosch and Bos are not sure yet if an extension of the directive certificates will lead to additional workloads for the notified bodies and how legacy products are supposed to be monitored during the extended transition period.
 
“It is also not clear how the conditions to get the extra time (e.g. that the manufacturers need to hand in an MDR application to the notified bodies) will be executed. Does the full technical dossier have to be submitted or will only an application form be sufficient,” Hoekstra-van den Bosch and Bos asked. “That decision could determine the successfulness of these measures. In addition, this might add to the existing workload of notified bodies.”
 
They also point out that the successful transition of combination products and companion diagnostics will need the full cooperation of pharmaceutical authorities. They note that if the legal proposal is accepted, conflicting guidances need to be amended as soon as possible.

 

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