Europe faces 2024 bottleneck in device reapprovals as submissions slow

Dive Brief:

The backlog of medical devices that need certifying under the new European Union regulations fell by 5% from April to October, according to a survey of notified bodies.
As of October, there were almost 23,000 valid certificates under the old directives. The devices covered by the certificates need to be certified under the new Medical Devices Regulation by May 2024, in some cases earlier, to stay on the market.
While most of the certificates are set to expire in 2024, officials are pushing for companies to apply for MDR certification early, the latest survey found no increase in the pace of submissions.

Dive Insight:

Changes to the MDR timeline mitigated the threat of immediate disruption to device supply, although it left the industry facing a bottleneck in 2024. To quantify the backlog, the European Commission surveyed the notified bodies designated under the directives.

The survey showed that there were 22,793 valid directive certificates as of October, down from 24,073 in April. Most, or 17,095, of the certificates are set to expire in 2024. If companies wait until close to the deadline to seek MDR certification, demand may overwhelm notified body capacity and leave applicants without the paperwork they need to continue selling their devices after May 2024.

Notified bodies are organizations designated by EU member states to assess whether regulated products meet technical requirements before they can be sold in Europe.

In June, European officials said it is “essential” that manufacturers seek certification “as soon as possible and well in advance of the end of the transition period.”

The request has yet to translate into an increase in activity. From September 2021 to April 2022, companies submitted 2,268 applications for certification under MDR. Between April and October 2022, the figure was 1,932.

While the rate of submissions has yet to accelerate, it’s still outpacing the speed at which notified bodies are issuing MDR certificates. The number of MDR certificates increased from 1,069 to 1,990 between April and October. As such, the pile of applications under review at notified bodies grew by 20%. The European Competent Authorities for Medical Devices is the latest group to comment on the situation.

“While measures to improve the efficiency of application of the regulatory requirements to address the capacity bottleneck are currently in the process of being implemented, a focused European discussion should also be conducted involving experts and decision makers from the Member State authorities, the EU Commission and including, when appropriate, relevant stakeholders, identifying how best to support and deliver on the implementation and practical application of the MDR and IVDR [In Vitro Diagnostic Regulation] for the benefit of European citizens,” the group said.