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When Will the EU MDR Burden Begin to Ease?
Disruption persists, but there are signs of improvement.
Heather R. Johnson
January 29, 2024
7 Min Read
Image credit: Dmytro Yarmolin / iStock via Getty Images
Zap-X, a gyroscopic radiosurgery robot developed and manufactured by Zap Surgical, received a CE mark in 2021 under the European Union’s Medical Device Regulation (MDR). Zap Surgical CEO John Adler, MD, said the process took roughly twice as long and cost twice as much as the FDA 510(k) regulatory pathway, which the device successfully cleared in 2017.
John O’Dea, chief executive of Palliare, a medical device manufacturer headquartered in Ireland, told Reuters it took over a year-and-a-half and about €100,000 to receive certification for the company’s EVA15 laparoscopic and endoscopic insufflators under EU MDR. Under the previous Medical Device Directive, the process took a few months and around €15,000.
EU MDR went into full effect in May 2021 with multiple transitional period extensions for legacy device certification. It’s a substantial departure from the previous Medical Device Directive, and it continues to evolve.
The regulations have caused their share of disruption due to shifting deadlines, ambiguities, and redundancies, not to mention its more rigorous requirements. Rather than invest the time and money needed for recertification, some manufacturers are opting to pull legacy devices from the EU market.
An April 2022 survey from MedTech Europe, a trade association representing medical technology industries, found 50% of the 475 respondent companies were planning portfolio reductions. Those considering portfolio reductions expected to discontinue about 33% of their devices.
“The industry cannot afford to stay in a system with so many moving targets and uncertainties,” said Muna Kebede, senior consultant for Akra Team, a medical device consultancy based near Munich, Germany. “The lack of clarity, on top of timeline pressures, before the system is fully developed, is a driving factor in the burdens experienced by medical device companies.”
Some kinks are to be expected from a substantial set of new regulations. Adler says his company experienced quite a few “wrinkles” as his staff, the notified body, and regulators worked together in the early days of EU MDR.
“It was a learning experience for all of us,” he said. “We chased our tail a bit trying to determine what was and wasn't important. And a lot of my engineers, who would otherwise be making a better product, we're trying to either massage the product or massage the application to meet requirements.”
The effort and expense paid off, as Adler says Zap-X has had success in the EU market. In 2023, Zap Surgical installed the device in healthcare organizations in five European countries. But given the expense and timeline—the average time to process a certification ranges from 18 to 24 months—many argue MDR, as written, stifles innovation.
“For smaller startups it will change their innovation trajectory,” Adler said. “Investors are holding their feet to the fire about how quickly they get a product to the market, or they’re not going to get the next round of funding. So delays are not a benign thing, and I don’t think regulators realize that.”
Advocating for EU MDR change
In December 2023, MedTech Europe submitted feedback and a proposal to the European Commission to minimize and simplify reporting requirements. The organization argued MDRs “high amount of reporting, duplication and lack of efficiency…places disproportionate burden on manufacturers, competent authorities and notified bodies.”
The organization also stated that the “increased post-market clinical monitoring requirements, lengthy certification, and increased process unpredictability are creating barriers to placing and maintaining medical devices on the EU market with disproportionate impact on small and medium size enterprises (SMEs).” The proposal cites its 2022 survey, which found that SMEs account for 26% of the total number of devices expected on the market by May 26, 2024, but will require 40% of the total certificates needed.
To protect innovation and help assure availability of legacy devices to patients, MedTech Europe proposed several amendments. Suggested revisions to eliminate confusion include removing redundant requirements and resolving conflicting interpretations of Medical Device Coordination Group (MDCG) guidance documents. To lessen burden, the organization wants to adjust some reporting requirements, including changing the periodic safety update report frequency from annually to every three to five years.
At the start of the year, two German members of the European Parliament (MEPs) submitted additional demands to refine EU MDR. Peter Liese and Angelika Niebler presented a 10-point list of demands to the European People’s Party, a European political party, to persuade the European Commission to amend the regulations.
The MEPs want the Commission to introduce programs similar to the FDA’s Orphan Product and Breakthrough Devices programs. The MEPs also want to remove the five-year recertification requirement for lower-risk products and expand the capacity of notified bodies.
“The ideas around reducing redundancies make sense, but we need to be cautious as well,” says Kebede. “Changes cannot be applied without clear rules, regulation, and supporting guidelines. If implementation is not made with a systematic change, it creates an additional burden.”
Encouraging EU MDR Trends
While policymakers, regulators, and advocates work to iron out EU MDR wrinkles, notified bodies appear to be making progress in the backlog of pending device certifications. In September 2023, during a session at BIOMEDevice Boston, Antal Solyom, director of the Medical Device Unit at HungeroTrial, said 2,950 certificates were issued under MDR as of March 2023 and 38 notified bodies were managing a backlog of about 23,700 certificates issued under the Medical Device Directive (MDD).
More recently, an ongoing European Commission survey monitoring MDR activity reports 3,941 certificates issued as of August 2023. It also reports 16,664 total applications received with over 10,000 written agreements signed.
In addition to an improvement in the case backlog, anecdotal evidence shows it is not as difficult (though still not easy) to find a notified body as in years past. The number of notified bodies has increased from 39 to 43 as of December 2023.
Tips to streamline the CE marking process
The process from evidence to CE mark will likely remain time-consuming, resource-draining, and expensive for the foreseeable future. Medical device manufacturers can save themselves some hassle, time, and expense by following a few best practices.
Start planning for the quality management system, clinical evidence, and clinical evaluation under MDR, and for the FDA, early and often. Make sure to have the appropriate scientific rationale to support MDR requirements. And make sure to meet project goals within the QMS or adjust QMS to maintain MDR certification. Companies that wait too long often spend unnecessary resources, such as hiring outside contractors, to meet these requirements.
Develop technical documentation in the manner regulators want to see: clear, organized, readily searchable, and unambiguous.
Contract with a notified body and start a dialog with that company as early in development as possible. Notified bodies cannot provide full regulatory or scientific advice, as the EU does not have a formal process akin to the FDA’s Q-Submission (Q-Sub) Program. Kebede says manufacturers can, however, enter a structured dialog to clarify certain formalities and specific expectations in advance of submitting technical documentation.
Contract with the right notified body. Reach out to prospective notified bodies to make sure your device is within the scope of their services. According to the European Commission survey, of the MDR applications rejected, nearly half (48.26%) were refused because they were out of scope of the notified body’s designation. Incomplete applications (18.56%) and incorrect qualification of product/classification of the device (17.17%) were the other top-two reasons for rejection.
North America and Europe remain the top two medical device markets in the world. Manufacturers that want to compete on a global scale must comply with MDR, no matter how onerous. In the MDD era, manufacturers often sought CE marking before an FDA premarket submission because it was faster and less expensive. The tables are turned now, but commercialization in both markets is feasible with advance planning—and funding.
“You can't be a worldwide business without being in the EU,” said Adler. “Now would be a great time for the EU to take stock and determine how to streamline what they’ve got.”
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