Medical devicemakers in the European market are one step closer to securing a bit of breathing room after saying new regulatory laws could lead to product shortages among their businesses.
The European Commission adopted a proposal Friday to delay the full implementation of the new Medical Device Regulation, or MDR. According to the commission’s announcement, the proposal will now be sent to the EU’s parliament and council, where final approval is set to arrive through an “accelerated co-decision procedure.”
Stella Kyriakides, the EU’s health commissioner, proposed the delay last month as complaints about stricter regulations and the high costs and long waits to comply with them reached a fever pitch.
Indeed, in a Reuters report last month, several devicemakers shared that they’d been forced to significantly pare down their European portfolios. In some cases, they said, recertifying an already-authorized device could cost 10 times as much as the original, pre-MDR certification and could take more than two years, compared to the previous timeline of just a few months.
“We are facing a risk of shortages of life-saving medical devices for patients. This is a risk we cannot take,” Kyriakides said in an early December speech. She noted that supply chain shortages caused by the COVID-19 pandemic and the Russian war in Ukraine were compounding the holes left in the market as devices were removed to comply with the new regulations.
Under the proposal newly adopted by the European Commission, devicemakers will have until the end of 2027 to recertify their high-risk devices that were previously approved for sales on the continent. Meanwhile, the transition period for their medium- and low-risk products will last through 2028.
That adds several years of padding to the originally proposed transition timeline, which asked that all devices be reauthorized by May 26, 2024, giving medtech makers just three years from MDR’s 2021 effective date to comply with the new regulations.
The new proposal also addresses the “sell-off” provision included in the original rule. Under those terms, any previously approved devices that hadn’t been recertified but were still available for purchase would have to be completely removed from the market by May 26, 2025. The update, however, seeks to eliminate the sell-off rule, a move that will “ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need,” according to the commission.
However, in its adoption of the proposal, the commission didn’t offer solutions to the main obstacles standing between devicemakers and recertification: high costs and long wait times, the latter of which is largely linked to a lack of notified bodies that have been authorized across the EU to review MDR applications.
Amid these extensions, the proposal doesn’t alter any of the newly introduced regulations, and new products are still required to be authorized under MDR before hitting the market.
The EU began the process of tightening its medical device regulations after a handful of scandals arose centering around the sale of counterfeit devices on the continent. The case most often highlighted is that of Poly Implant Prothèse, a French company that was found in 2010 to have been illegally replacing the medical-grade silicone in its breast implants with a cheaper, industrial-grade alternative for years. The illicit swap was associated with a huge increase in the number of implant leaks and ruptures and was pinpointed as the cause of several deaths and cases of breast cancer.
By 2017, the European Council had proposed MDR to prevent such a scandal from occurring again. The rule took effect in May 2021, following a one-year delay caused by the COVID pandemic.