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Editor’s note: On February 16, the European Parliament officially approved extending the transition period of the Medical Device Regulation. The amendment will take effect immediately upon publication in the Official Journal of the European Union.
By now, you’ve likely heard that the European Commission has proposed postponing the Medical Device Regulation (MDR) transition deadline — again. While the announcement may bring a sense of relief to orthopedic device companies, regulatory experts advise that companies stay the course with their strategy.
“Don’t think of this is a delay of MDR,” said Michelle Lott, Principal and Founder of LearnRAQA. “It is an extension, provided that specific criteria are met. A lot of speculation is going around based on what industry wants — a true delay of MDR.”
You’ll remember that EU MDR was also postponed in 2020. Even with additional time, orthopedic device companies and Notified Bodies have struggled with implementation.
Lott noted that more than 8,000 MDR applications had been submitted, and about 2,000 MDR certificates had been issued.
What Is the EU Commission Proposing?
The European Commission’s latest proposal gives more time to certify medical devices from Medical Device Directive (MDD) to MDR. It’s an effort to mitigate the risk of device shortages.
“The availability of safe medical devices for European patients is our priority,” the Commission said. “This proposal does not change any of the current safety and performance requirements provided for in the MDR. It only amends the transitional provisions to give more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation.”
The proposal contains a few key elements worth highlighting:
- The transition deadline of May 26, 2024, has been extended to December 31, 2027 for high-risk devices and December 31, 2028 for medium- and low-risk devices.
- The proposal extends the validity of certificates issued before May 26, 2021, when the EU MDR originally became applicable.
- The proposal also removes the “sell-off” date established by MDR. By eliminating the date by which devices on the market must be purchased, the Commission hopes to ensure safe and essential medical devices are available to patients.
The European Parliament and Council are expected to vote on the final approval in the coming months. Until then, the postponement remains a proposal.
“The vote will require all Competent Authorities to come to a consensus,” Lott said. “Among language barriers, various stakeholders (Competent Authorities, Notified Bodies and industry) and the extensiveness of the regulation, this will be a monumental challenge. I also want to be clear that nothing is finalized. Many in industry are eager to think this extension is already in effect.”
What Isn’t the Commission Proposing?
The European Parliament and Council initially adopted MDR in 2017. Orthopedic companies have navigated this regulatory change for years. They’re intimately familiar with the burdens of achieving MDR certification — high costs, stringent requirements and long wait times due to limited Notified Bodies. The postponement’s conditions offer no support or solutions to alleviate these hurdles.
Before the postponement announcement, Lott and her regulatory peers had advised medical device companies to submit their documentation to Notified Bodies at least 18 months before their MDD expiration date. The process is long and filled with discrepancies.
“Transparency and consistency across Notified Bodies in the interpretation of the regulation still poses the biggest challenge,” Lott said. “The application of MDR from Notified Bodies is extremely inconsistent in their quality system audits and technical documentation reviews.”
Orthopedic companies that are working with multiple Notified Bodies must continue to press the firms for clear directions and timelines to ensure that manufacturers meet regulatory requirements.
What Should Companies Do Now?
In practicality, how should orthopedic companies proceed with their strategy over the next six to 12 months?
Companies that are well into the review process with a Notified Body should proceed with their efforts, Lott said. “Over-communicate with your Notified Body about anticipated timelines and internal interpretations of possible extension options and qualification criteria,” she said. “As a backup, prepare a data package per MDCG 2022-18 for a derogation under MDR Article 97.”
Article 97 is an exemption clause intended to allow a device to remain on the market despite documented non-conformances as long as the device is low-risk and the non-conformance is resolved within a defined period, according to Lott. The proposed extension shifts the purpose of Article 97. It allows EU Member State Competent Authorities to decide that a device can remain on the market without a valid CE Mark. However, to qualify, manufacturers must show evidence (Notified Body, technical documentation, etc.) that they are working toward MDR certification.
Lott advised that companies at the MDR starting line should analyze their product portfolio and determine whether MDR makes sense from market access and financial standpoints. Further, they should be realistic about timing. Manufacturers face a timeline of more than a year to get an initial review with a Notified Body.
“Begin communication with a Notified Body as soon as possible and take advantage of their publicly posted fees,” Lott said. “Understand you may be looking at 12 months just to get an MDR compliance quality audit, and many Notified Bodies are not even accepting new clients at this time. If you already have a good relationship with a Notified Body, make sure they are designated to review your product under MDR with the correct Notified Body code.”
Regardless of how long a company has been working on the MDR transition, those doing the work have struggled to communicate realistic milestone dates to their executive teams and investors, Lott said. That challenge is likely to continue if the transition deadlines are extended.
“The best advice is to go in with patience and very clean technical documentation,” Lott said. “For legacy products, that means investing in new testing to bring devices in line with state-of-the-art requirements. With all the reviews Notified Bodies are under pressure to complete, they have very little tolerance for accepting justifications and old testing.”
