European Parliament votes to extend MDR transition period

Updated 17 February to clarify a statement by Erik Vollebregt on product shortages.

The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in the economic region. The vote also supported nixing the sell-off date provision for existing products specified in the MDR and In Vitro Diagnostic Medical Devices Regulation (IVDR).

In a 537-3 vote, with 24 abstentions, the European Parliament adopted a proposal by the European Commission to delay the transition period due to concerns about device supply, notified body capacity and manufacturer preparedness. The vote was taken by Katarina Barley, vice president of the European Parliament, and the parliamentarians decided to move forward with the vote without a discussion due to the urgent nature of the legislation.

The amendment comes after a 6 January vote on the same proposal was approved by the European Commission. European Health Commissioner Stella Kyriakides first proposed the postponement late last year to avoid tens of thousands of medical devices going off the market because they could not meet MDR requirements. (RELATED: European Commission moves to delay MDR transition, Regulatory Focus 6 January 2023)

The European Parliament said it will skip the typical 20-day waiting period before publishing the amendment in the Official Journal of the European Union due to the urgent nature of the amendment. The amendment will take effect immediately upon publication in the Official Journal.

Erik Vollebregt, a partner at Axon Lawyers, noted that the MDR date of application was previously pushed back from May 2020 to May 2021 in a similar process and that the amendment only took about a week to be published at that time. While there is no certainty the process will be that quick in this instance, Vollebregt told Focus that he suspects lawmakers will try to publish the amendment sooner rather than later.

Whether the amendment will be enough to stave off a product shortage in the Union market depends on who you ask, according to Vollebregt.

“I know that the Commission thinks they have given maximum flexibility with this proposal, and of course, the work on implementing the actions defined on MDCG 2022-14 to free up more notified body capacity will continue to be pursued,” he said. “Personally, I think a lot will depend on how member states and the MDCG allow notified bodies to be part of the solution and also police them on behavior that is not helpful.”

Gert Bos, executive director of the Qserve Group, and Sabina Hoekstra-van den Bosch, vice-president of Team-NB, told Focus they are optimistic about the move and think the amendment will generally be sufficient to prevent shortages of specific types of products, though some may fall through the cracks.

Bos added that there were some issues that were raised during the public query process, but ultimately lawmakers decided to move quickly and decisively without splitting hairs over some of the details.

“Some of the cracks might be dealt with easier using the derogation clause in article 59 of the MDR, or the special route from article 97 of the MDR,” he told Focus. “Some other issues are likely to be clarified further in guidance, of which we expect a lot to be published this side of summer to clarify many of the questions on the implementation of the delay in practice.”

The experts said there are other measures EU authorities can take to further prevent device shortages.

“It would really help if [the authorities] would insist on transparency from manufacturers around which products will be moved into MDR, and which ones will be taken from the market, and if the latter, in what timeframe,” Hoekstra-van den Bosch told Focus. “Thus, health care providers will get more time to look for alternatives and how they best can help their patients.”

Vollebregt added that the European Parliament may also want to call on the EU Commission to adopt additional legislation to fix problems that persist in the device regulatory system and can monitor Medical Device Coordination Group (MDCG) in the roll-out of the MDCG 2022-14.

“I think the way that the member states instruct their notified bodies to be part of the solution needs to remain subject of scrutiny and politics,” he added. “As I see it in practice, member states may agree one thing in the MDCG but then still do not give their notified bodies sufficient room to actually make a difference.”

Passage of the amendment may also have some unintended consequences, according to the experts. Bos noted that since there’s been talk of extending the MDR deadlines, some companies have slowed their pace to comply with the regulation, in some cases to prevent burning out their staff, though he worries that others have decided to not prioritize the transition because they expected an extension.

“The best thing to do is to continue to push for completion and provide the notified body with timely dossiers for review,” said Bos. He added that this includes ensuring they are generating sufficient clinical data and try get the product submission right the first time.

“To quote the well-versed IVDR guru Sue Spencer on the IVDR delay from 2022: ‘Don’t take your foot off the gas!’” he added. “That seems to be equally applicable now to the MDR delay.”

Vollebregt also noted that the amendment is a very technical document that isn’t clear on certain points, and there are likely to be divergences in interpretations of the text. He added that the European Commission is working on a Q&A document that they plan on presenting to stakeholders at a meeting on 13 March that may help resolve any questions regarding interpretations.

Hoekstra-van den Bosch said it’s important to remember that the amendment is fixed around specific deadlines, pointing the deadlines for applying for a conformity assessment under MDR and signing a contract with a notified body, which fall in May 2024 and September 2024, respectively.

“Experience until now has been that a substantial part of manufacturers will come in the end period just before the deadline,” she said. “This could lead to ‘queueing’ just before the deadlines again. Although notified bodies have been ramping up capacity and the number of MDR designated notified bodies is growing, notified body capacity to process applications is not endless.”

Hoekstra-van den Bosch also noted that deadlines are set when the conformity assessment process for MDR needs to be completed, which is the end of 2027 for high-risk devices and the end of 2028 for lower-risk devices. She added that in this situation, manufacturers should also submit sooner rather than later to avoid queuing.

“This can only be achieved, if manufacturers, despite the extra time given, keep on working on their MDR transition and come with applications and work with notified bodies on the conformity assessment well in advance of the deadlines,” Hoekstra-van den Bosch added.

The bottom line for Vollebregt is that it’s game time for companies that make legacy devices. Management and regulatory affairs staff at impacted companies should understand that this is not a blanket extension for their products but rather they need to meet certain criteria such as MDR readiness and an MDR application at a notified body by 26 May 2024.

“Accordingly, the amendment is not intended to give industry more time but is intended to only give notified bodies more time to process the huge pile of applications that had amassed towards the end of the grace period,” he added. “Any devices company that misunderstands this is making a critical mistake and will miss its launch window for extension, inevitably leading to a period of not being able to place devices on the market in the Union until MDR CE has been obtained.”

Bos says companies need a number of key clarifications from notified bodies on conformity assessment that is part of the rules to use the delay for specific products. He said that so far notified bodies have used a quick scan review on the technical documentation as part of accepting the work.

“So, the first line technical scan was done prior to issuing a quote / signing an agreement,” Bos added. “If they need to continue that process, then much of the effect of the delay may be compromised.”

In particular, he said he wants to see clarification for users in the EU, as well as foreign agencies, about which specific products and certificates fall under the delaying process. He also called for clarification on whether the UK will accept the old CE certificates for a longer period.

Hoekstra-van den Bosch said she wants to see more clarification on the concept of a ‘device intended to substitute a legacy device’ which she said is a new concept.

“If an application is lodged for a ‘device intended to substitute a legacy device’, the original legacy device, although different from the ‘device intended to substitute a legacy device’ can benefit from the extended timelines until 2027/2028,” she said. “Although there is logic in this, why would a manufacturer and a notified body work on MDR transition for a device that is not intended to be marketed because it will be substituted by another device, how this concept will work in practice still has to be hashed out.”

“The EU Commission has encouraged notified bodies and manufacturers to liaise as much as possible to propose solutions,” she added. “In addition, EU Commission has announced they will organize webinars with stakeholders to work on implementation solutions.”

Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their individual views only.

European Parliament votes to extend MDR transition period

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