Will the EU Medical Device Shortage Be Delayed?

The rollout of the EU’s new regulatory system—Medical Devices Regulation (MDR)—has created trepidation and concern almost since its inception. The new system adds requirements to the MDD (Medical Devices Directive; EU’s previous regulatory system) without removing anything from the former system. Additions cover specific devices that don’t have an intended medical purpose, reprocessed single-use devices, disinfection and sterilization technologies, active implants, and others. Further, changes were made to the device classifications, requirements for clinical evaluation and the post-market surveillance system, and more, in addition to the implementation of a unique device identification system.

The MDR was put into play on May 26, 2017, which is when notified bodies could apply for designation under the new system. That seemed to be slow going and concern over the rate at which notified bodies were approved grew. To complicate matters further, any notified body in the U.K. was no longer able to issue a CE certificate for the EU due to Brexit (the British exit from the EU). In addition, I was hearing anecdotally that a number of notified bodies simply didn’t want to be certified to MDR and were unwilling to meet the new standards.

Then, of course, the world shut down for a time due to the COVID-19 pandemic. This clearly created an unforeseen circumstance in which no one could logically expect the MDR transition to occur on May 26, 2020. As a result, the European Commission (EC) proposed the postponement of the regulation for a year.

Unfortunately, the effects from the pandemic lingered for a much longer time than most expected. As such, many called for the EC to issue another delay to the changeover, but in October 2020, the organization announced there would be no further delay. Thus, on May 26, 2021, the EU moved to the MDR system for the issuance of CE certificates. Now the countdown was set for termination of the sale of devices still permitted under the MDD. These certificates would become void on May 26, 2024. Again, concern grew.

Regulatory professionals urged medical device manufacturers to begin their MDD to MDR conversion if they hadn’t already for their products currently on the market. It was reported the MDD certificates for as many as 30% of medical devices on the EU market would expire by the 2024 date without being renewed. In fact, in a Team NB (The European Association for Medical Devices of Notified Bodies) position paper, it was determined the CE certificates for approximately 13,000 devices on the EU market would expire from 2020 through 2024. This would undoubtedly lead to product shortages, potentially affecting the quality of healthcare available and the timeline for procedures. Given the backlog created by the MDR transition, there is no possible way for the process to be completed by the May 2024 date.

Recognizing this potentially dire situation, at the start of this year, the EC adopted a proposal to delay the expiration of the MDD certificates, as well as delete the “sell-off” deadline in the relevant MDR and IVDR provisions (thus, not requiring the destruction of safe medical devices already on the market).

The EC stated in its proposal, “Despite considerable progress over the past years, the overall capacity of conformity assessment (‘notified’) bodies remains insufficient to carry out the tasks required of them. In addition, many manufacturers are not sufficiently prepared to meet the strengthened requirements of the MDR by the end of the transition period. This is threatening the availability of medical devices on the EU market.”

The new deadline for the transition, under the proposal, would be Dec. 31 in 2027 or 2028 (depending on the risk class of the device).

The proposal originated a month earlier during a meeting of the Employment, Social Policy, Health and Consumer Affairs Council in Brussels on Dec. 9, 2022. Europe’s health commissioner, Stella Kyriakides, noted, “We have been following the progress achieved towards this goal very closely in the past months and, while the number of notified bodies have increased and actions have been taken to prepare manufacturers, this is not enough.” She continued, “In addition, we are now experiencing supply shortages on the global market. We are still feeling the impacts of the pandemic, and now also the Russian war in Ukraine, where several manufacturers of devices are located. This is creating additional complications.”

Hopefully, your company has already begun to transition products currently on the EU market to the MDR and you weren’t keeping your fingers crossed hoping for a postponement. But alas, whether you were or not, it seems likely—pending the EU parliament’s approval—the timeline for your products on the EU market will be extended.  

Sean Fenske, Editor-in-Chief
[email protected]