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Last November, the European Commission’s Medical Device Coordination Group (MDCG) issued a position paper that presented the number of product applications submitted by medical device companies for EU MDR certification.
The news wasn’t great.
Data collected by notified bodies showed that only around 13,000 MDR applications had been submitted compared to the more than 24,000 certificates issued under the medical device directive. Further, only 3,900 MDR certificates had been issued, and around 1,000 of those were related to product updates.
The transition deadline for device companies to register products under the new MDR has been extended to December 31, 2027 for high-risk devices and December 31, 2028 for medium- and low-risk devices.
Some device makers are delaying product development efforts during the transition period because they think the extension affords them more time to act. That’s cause for concern.
“Many device companies are diligently progressing and maintaining momentum in the process. However, there are a few companies, including major players, that have slowed down due to the extension,” said Matthias Fink, M.D., Senior Clinical Consultant at the AKRA Team. “Companies that aren’t acting with a sense of urgency could create a backlog of applications in two or three years. That means some companies might struggle to meet the new deadlines.”
Two important deadlines in the MDR process are fast approaching: Companies must have an application in place for a conformity assessment and have a quality management system in place by May 26, and must sign a written agreement with a notified body by September 26.
“It takes about six months to get a contract in place with a notified body,” said Michelle Lott, Principal and Founder of leanRAQA. “I feel like a broken record by saying now’s the time to act if you haven’t already. Like, really this time.”
Room for Improvement
The MDCG paper reminded device manufacturers that the duration of the conformity assessment process, once applications are submitted to notified bodies, takes longer than it did under former directives. Contributing factors to the lengthier process include the incompleteness of manufacturers’ applications, according to the paper.
Dr. Fink noted that device companies sometimes submit data that are limited or contain outliers for various reasons, such as complex study populations with multiple health conditions.
“Presenting data without explanations or justifications can raise concerns for notified bodies,” he explained. “When there’s a discrepancy or data misalignment with the current standards, it’s crucial to provide a clear narrative that explains the anomalies.”
Submitting MDR applications is like crafting a story, according to Dr. Fink.
“The narrative should flow logically from start to finish, making sense at every step and concluding with a clear understanding of how the device works,” he said. “Notified bodies appreciate a coherent explanation that aligns with the data presented. When there’s a gap or something seems amiss, they’ll dive deeper to understand why.”
Applying for MDR certification requires a team of multidisciplinary experts to tackle the clinical, technical and regulatory requirements, according to Lott.
“The days of having one regulatory person in charge of every aspect of the application process are long gone,” she said. “The requirements have become highly specialized and in-depth. You need a comprehensive team working on the process if you’re attempting to manage it internally. Otherwise, you’ll end up working with multiple consultants with different specialized skill sets.”
The process is far from perfect, even for a team of experts. Lott knows of a company that worked for more than a year to receive a proposal from a notified body with which it already had a working relationship.
“The application process was burdensome,” she said. “The notified body kept altering their forms for requests for quotes, so every time the company submitted the required paperwork, a new form needed to be filled out, which required starting the process over again.”
MDCG is aware of the difficulties involved in obtaining certification and has called on notified bodies to make the process more efficient, transparent and predictable. The position paper reminded notified bodies to follow consistent, fair and reasonable terms and conditions.
Notified bodies should assist device manufacturers by providing regulatory guidance and technical information on how to apply for conformity assessments, according to MDCG, which noted this would lead to a smoother and faster process and help to avoid incomplete applications.
MDCG also reminded notified bodies to organize structured dialogues with device manufacturers and said that this communication should be part of the normal pre-application and conformity assessment process, not a service that can be charged for separately.
Major players like DePuy Synthes and Medtronic, among others, appear confident in their understanding of the application process and have initial MDR projects underway, according to Dr. Fink.
He suggests that device companies treat their initial dealings with a notified body as a pilot project and wait to get valuable feedback on the first documentation. “Treat the first deficiency report as a valuable learning opportunity,” Dr. Fink said.
This allows companies to make necessary adjustments to the process before moving forward on multiple applications for numerous products.
Dr. Fink has researched scientific opinions published by expert panels on the level of medical device regulatory oversight in Europe. “Most of these opinions highlight insufficiencies in data or a lack of a clear benefit/risk ratio,” he said. “Device manufacturers should study these opinions and the identified gaps to ensure their devices don’t face similar pitfalls in the application process.”
Market Access Concerns
Public outcry over Poly Implant Protheses (PIP) breast implants made with industrial-grade silicone gel in the early 2000s accelerated the shift toward stricter medical device regulations due to concerns that the European government wasn’t adequately safeguarding patients. MDR was the result of the perceived need for a regulatory correction.
Now some experts are wondering whether the medical device regulatory pendulum has swung too far in the opposite direction.
Device manufacturers are also increasingly concerned about the rising expenses tied to obtaining and maintaining MDR certification, which requires recurring fees for annual or biannual postmarket surveillance updates, Periodic Safety Update Reports and Summary of Safety and Clinical Performance updates.
“These cumulative costs might lead some companies to reconsider staying in Europe, potentially resulting in certain devices being removed,” Dr. Fink said.
He added that the prevailing challenge of getting new and innovative devices to market in the EU has sparked a growing trend: Orthopedic companies with novel technologies first seek FDA 510(k) clearance, which is a comparatively simpler process, followed by data collection that can be used for MDR compliance.
“This approach might become more common, especially for class II devices in the U.S. and class III devices in Europe,” Dr. Fink said.
Lott said smaller companies face the prospect of spending more money to get their products into Europe than they stand to make from selling them. Startups are bearing the brunt of the MDR burden, and those are often the companies that help drive innovation.
The challenges associated with the EU market are worrisome, but there’s a lack of awareness among the public and healthcare professionals regarding the severity and reality of this situation, according to Lott. She believes concerns caused by a potential shortage in medical devices will prompt a more permanent solution to the market access problem.
There is a way for device manufacturers to make their opinions known about the MDR application process and the challenges that need to be addressed. The European Commission has sponsored an online survey that will be used to obtain information from device manufacturers and authorized representatives about the availability of medical devices on the EU market. The company-neutral aggregated data that is collected will be analyzed to produce synopsis reports moving forward.
“We’re still navigating the learning curve of MDR compliance,” Dr. Fink said. “It’s an ongoing process that demands device manufacturers to be well-prepared. Studying expert opinions and learning from the feedback is paramount to progressing under the MDR regulations.”
