Experts: MDR transition delay needs clarification, industry engagement to succeed

Regulatory NewsRegulatory News | 10 January 2023 |  By 

Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the development of new guidances, according to experts who spoke to Focus. They also said that manufacturers need to take advantage of the extension and not wait till the last minute to submit their applications.
 
Over the past year, stakeholders have voiced grave concerns that the deadline for manufacturers to transition from the previous medical device directives to the MDR will force tens of thousands of products off the European market and endanger patients. One of their chief concerns has been the lack of notified body capacity to review all the products that need to transition to the new regulations.
 
Heeding those concerns, the European Commission on 6 January adopted a proposal to extend the MDR’s transition period to 2027 or 2028, depending on the risk level of the device. The Commission also proposed repealing the “sell-off” date provision under MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). (RELATED: European Commission moves to delay MDR transition, Regulatory Focus 6 January 2023)
 
Whether the delayed transition will pay off depends on multiple factors, according to several EU medical device experts.
 
While the lack of notified bodies to handle the expected avalanche of applications from manufacturers has been a major concern, it isn’t the “only piece of this puzzle,” according to Erik Vollebregt, a partner at Axon Lawyers.
 
“The competent authorities and the MDCG have to do their part in the roll-out of MDCG 2022-14, which is essential to make notified bodies function more effectively and be able to put this extra time to good use,” he told Focus.  He also noted that in the past, manufacturers have too often submitted sub-par conformity assessment applications.
 
“Medical devices companies' management has to approach this as a strategic matter with their union turnover at stake,” said Vollebregt. “I see many devices companies where management just does not get this and is only interested in hearing about the next MDR delay or exemption, which is misguided.”
 
Vollebregt adds that the issue is especially important in when it comes to mergers and acquisitions, and that companies need to check a manufacturer’s MDR transition strategy to ensure they’re ready for the EU market. He added that he’s seen both acquiring companies and the firms they are acquiring making costly mistakes and putting their products in danger of not being marketable.
 
Gert Bos, executive director of the Qserve Group and chairman of the Regulatory Affairs Professionals Society’s (RAPS) board of directors, agreed that manufacturers should avoid procrastinating until they’re too close to the new deadline. He told Focus that the notified bodies have used their projected workloads and available resources to calculate how much more time they need to ensure products are ready to transition to EU MDR, and based on that, it seems like the new deadlines are more doable but there’s a “big if.”
 
“The calculations presume the notified bodies will always have enough work ahead, and manufacturers are not procrastinating, there is no unforeseen delay in review and answer rounds,” said Bos. “In other words, if all push forward, the MDR transition might be a success … the serious bulk of extra time appears to allow products to be reviewed in a timely fashion if manufacturers timely provide their documentation, and any updates as required during review.”
 
However, Bos is less confident about the ability to transition to the IVDR as there’s a gap between the potential review capacity of IVDR notified bodies and their actual resources. He noted that some notified bodies are also acting as Auditing Organizations under the Medical Device Single Audit Program (MDSAP) and supporting the United Kingdom Conformity Assessment (UKCA).
 
“If either of these schemes requires a lot of resources simultaneously, realizing there is significant overlap with the resources used for the MDR/IVDR work, there might be some additional stress on the system ahead,” Bos cautioned.
 
Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD and a RAPS board member, told Focus the new timelines proposed by the Commission are generous and give notified bodies, such as hers, sufficient time to transition products to the MDR.
 
“Having said this, transferring to MDR ahead of the new timelines still brings a lot of benefits,” she added.
 
While the proposal to push back the MDR transition period is meant to resolve some of the issues with implementing the regulation, there is still a lack of clarity on issues such as how the risk level of individual devices will be assessed to determine which deadline they must meet, Vollebregt said. He wants to know who will be charged with evaluating that a device does not present an unacceptable risk and what criteria they plan to use. He also said he wants to know what the process is for manufacturers if they have to fully implement MDR quality management system requirements before the 26 March 2024 deadline and who will oversee that, and whether it is part of appropriate surveillance duties of notified bodies under the Active Implantable Medical Devices Directive (AIMDD).
 
“The consequence is that we will need a considerable amount of new MDCG guidance to be able to implement the amendment, and the MDCG has been way to slow in delivering important guidance in time,” said Vollebregt.
 
Bos noted that there are other wrinkles that the deadline extension may not be easy fix for. For instance, he said that some foreign authorities who are used to reviewing EU certificates for local registration will need to be briefed on the new transition plan. He also noted that companies who have asked for certain exemptions under the MDR, such as waiver of CE mark, may also face some difficulties.
 
“The unclarity of the transition is adding a lot of burden to the renewal processes of market entry around the world,” said Bos. “That will continue or potentially worsen.”
 
“Another thing to consider is the recently expired certificates for legacy products where the MDR review was not concluded in time,” he added. “Hopefully, these ongoing reviews will be prioritized by the notified bodies.”
 
Hoekstra-van den Bosch noted that more clarity is needed from regulators on some of the technical implications of the proposal.
 
“While notified bodies welcome the proposal, it includes some details that need further elaboration on a technical level,” she said. For example, she said more clarity is needed on devices that are intended to replace legacy devices and how provisions covering legacy devices will be implemented in situations where their certificate has already expired.
 
Similarly, Bos said that the proposal currently is “very generic,” and a lot of the details will need to be hashed out in additional clarifying guidances.
 
“Getting to workable solutions will undoubtedly take some further time after the legislation has been passed,” he added.
 
Vollebregt said it’s also important to look out for the “IVDR effect” which resulted from IVDR manufacturers kicking the can down the road when the IVDR deadline was extended. IVDR notified bodies have stated they have an excess capacity as a result but there’s concern that manufacturers will make a mad dash as the deadline arrives.
 
“For the MDR this may not happen, but manufacturers would do well to watch out for this and be ready to scoop up the slots immediately if this happens, and not wait,” Vollebrgt said. “It's so strange, everyone understands that you should not go Christmas shopping on the day before Christmas, but so many companies do not seem to understand that you cannot all go through MDR conformity assessment at the same time after having delayed until the last moment before the end of a deadline.”

 

© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

9;10;11;14;18;31;