The European Parliament this week formally agreed to delay the requirement for certain currently approved class 1 medical devices to comply with the new Medical Devices Regulation (MDR) when it comes into force on May 26, 2020. Consequently, manufacturers of reusable surgical instruments and devices that have a measuring function will have an additional four years to meet the stricter requirements of MDR.
Approval of the delay comes a week after the new EU health commissioner, Stella Kyriakides, admitted the modest end-of-2019 target of certifying 20 notified bodies to assess compliance with MDR, and with the new in vitro diagnostics regulation (IVDR), will not be met. With less than six months to go to the deadline for companies to upgrade medical devices certification, there are still only seven notified bodies able to conduct appraisals in compliance with stricter MDR requirements. In addition, two notified bodies have been under qualified IVDR, which is coming into effect in May 2022.
Despite this hole in the regulatory infrastructure, Kyriakides has told concerned health ministers she is sticking to the May 2020 MDR deadline. “A lot of work needs to be done to implement this legislation on time. It’s going to be a rough road, a bumpy road at times, but I will do my best to deliver on what my mandate has entrusted me with,” Kyriakides said.
Kyriakides was speaking at her first formal meeting with European health and social care ministers since she succeeded to the post of commissioner on Dec. 1, addressing the Employment, Social Policy, Health and Consumer Affairs Council last week. Although it was not the topic of the meeting, ministers concerned about how implementation of MDR is proceeding used “any other business” to raise the matter. Fifteen of them spoke on the item, underlining the level of shared concern about the need to ensure there are enough notified bodies.
They jointly called on Kyriakides to order a comprehensive review of the state of play at the beginning of next year, and for them to be given regular updates on progress.
There should be a “readiness assessment” early in 2020, said Lena Hallengren, minister of health in Sweden. Tanel Kiik, minister of social affairs in Estonia agreed, saying that would enable the European Commission, “to identify implementation areas that need more focus.”
Maggie de Block, Belgium’s health minister, said, “It is clear there is still lots of work to do, while it is also clear it is necessary to complete this work as early as possible.” A concrete plan is needed to achieve this, de Block said. “We strongly invite the Commission to speed up work on implementation.”
The chair of the meeting, Krista Kiuru, health minister of Finland, said the exchanges highlighted how industry and a large group of member states, “are worried certain central elements of the regulation are incomplete,” including the likelihood of a low number of notified bodies at the time of application of the regulation.
No one wants MDR to be delayed, with ministers agreeing timely implementation is essential for patient safety. But the need to try and create a bit of slack in the system by extending the deadline for currently approved class 1 devices to comply with MDR, at this late stage of the implementation process, is a telling illustration of how difficult it is going to be to deliver the regulation on time.
The proposal for the class 1 delay was put down not as an amendment to MDR, but as a corrigendum, a mechanism usually reserved for correcting minor errors or inconsistencies in the text of legislation.
While members of Parliament on the Environment, Public Health and Food Safety Committee gave initial approval to the change last month, they also took issue with the way it was introduced to MDR, saying it is inappropriate to change the substance of legislation in this way. Still, the committee felt obliged to support the corrigendum because MDR must be applied in May 2020.
The corrigendum is only addressing part of the problem, according to Maria Manley, partner at the London office of Sidley Austin LLP. “Many companies are struggling to comply with the new standards within the remaining six months left until MDR enters into force; and not for any fault of their own,” she said.
“There are not enough certified notified bodies to do the work and they are turning down applications from manufacturers,” Manley told BioWorld MedTech.
Kyriakides’ predecessor, Vytenis Andriukaitis, made the promise that 20 notified bodies would be certified by the end of 2019, when he appeared before health ministers in June. Even from that perspective, it looked like too little, too late, given that 51 applications had been received from notified bodies wanting to upgrade their certification.
Speaking to health ministers last week, Kyriakides said that in addition to the 9 designated to date, another 3 notified bodies will be approved by the end of 2019.
“There is still a lot that needs to be done, but on notified bodies, I wanted you to know that the designation process has significantly been speeded up over the past three months,” Kyriakides said. “We hope that by the first quarter of 2020, we will get up to 20 designations.”