Notified bodies warn MDR certification bottleneck could lead to medical device shortages

Dive Brief:

The number of medical device certificates due to expire in 2024 threatens to overwhelm notified bodies and create product shortages, according to a European trade group.
A survey by Team-NB, which represents European notified bodies, found 7,272 certificates are set to expire in 2024. Team-NB wants the European Union to act now "to avoid the risk of shortages of medical devices" beginning about three years from now.
The trade group said allowing remote audits under the Medical Device Regulation and asking manufacturers to seek certification before the 2024 expirations could help notified bodies.

Dive Insight:

The delay of the MDR date of application by one year gave the industry short-term relief. However, the decision to still void MDD certificates in 2024, effectively shortening the transition period by one year, raised the possibility that the delay would store up trouble for the future.

Team-NB has generated data to quantify those concerns by surveying all the medical device notified bodies. After reviewing responses from 34 notified bodies, Team-NB has sounded the alarm.

The survey found 7,064 MDD certificates and 208 active implantable medical device certificates are due to expire in 2024, the year certificates issued under MDD become void as part of the move to MDR. That means notified bodies would need to process more MDR certificates in 2024 than all of the four previous years combined. Team-NB found 6,723 certificates will expire from 2020 to 2023.

In practice, notified bodies will have more work to do in 2023 and 2024 than those numbers suggest as tasks beyond the voiding of MDD certificates, such as the reassessment of MDR designations, will also need completing. Team-NB set out the implications of the surge in expiring certificates.

"It is clear that in 2024 the number of expiring certificates will induce a peak in the workload of notified bodies that will be difficult to manage," Team-NB wrote. "It is definitely a challenge to be taken into consideration if we want to avoid the risk of shortages of medical devices in 2024 which could lead to risks for patients."

The other challenge Team-NB identified in the data is more immediate. Team-NB estimates almost 2,500 MDD certificates will expire in 2021 and the first half of 2022. The ability of notified bodies to convert those certificates to MDR is currently hindered by the impact of COVID-19, causing Team-NB to state an immediate solution is needed to avoid disruption to the availability of devices.

Team-NB proposed two actions to alleviate the pressures on notified bodies. The trade group wants authorities to encourage manufacturers to make MDR submissions before their MDD certificates end in 2024, thereby spreading the workload of notified bodies more evenly over the next few years.

The other suggestion covers remote audits. With the pandemic limiting travel and in-person meetings, the EU permitted notified bodies to conduct remote audits under MDD. A recent survey of Team-NB members suggests remote audits have been mostly successful but authorities are yet to extend the model to cover the bulk of MDR work.

Team-NB wants that to change. The trade group sees the allowance of remote MDR audits as a way to enable notified bodies to get through more work now. Preventing notified bodies from completing MDR work until after the pandemic abates could exacerbate the bottleneck evident in the Team-NB survey data.