Notified bodies are taking up to a year to carry out conformity assessments of COVID-19 medical devices and diagnostics, according to a recent European Commission survey.
The poll found 55% of notified bodies would expect to spend six to 12 months processing applications for certain Class IIb devices that are essential to the response to COVID-19. One in six notified bodies are not accepting new applications.
- Notified bodies shared the information weeks after the Commission called for them to prioritize COVID-19 conformity assessments amid concerns the process can take “several months.”
The Commission called for notified bodies to prioritize COVID-19 applications in a document that set out a roadmap to the lifting of measures to contain the spread of the virus. In the document, the Commission also vowed to share information on the availability and capacity of notified bodies. The commitment formed part of a wider push to increase supplies of medical equipment.
To gather information on conformity assessment availability and capacity, the Commission surveyed 37 notified bodies in May. The survey asked notified bodies for the average times for completing a range of activities related to COVID-19.
Under the outgoing Medical Devices Directive, one-third of notified bodies are either not accepting new applications for essential COVID-19 devices or have a waiting list of more than one month. The duration of the conformity assessment itself depends on the type of device being assessed.
Most notified bodies are taking one to three months to complete conformity assessments of Class I devices under MDD. One-third of notified bodies are spending more than three months on Class I devices.
Notified bodies are taking considerably longer to process higher-risk devices. Around half of notified bodies are spending three to six months on conformity assessments of Class II devices. Waits of six to 12 months are common for Class IIb devices.
The Commission said “it is important to note that in the current context, notified bodies can see their ability to carry out conformity assessments reduced, given the limited capability to carry out on-site audits.” The survey took place a month after the Commission's Medical Device Coordination Group cleared notified bodies to audit companies remotely during the pandemic.
Notified bodies also shared information on timelines for conformity assessments performed under the Medical Devices Regulation. Depending on the type of device, between 58% and 86% of notified bodies said questions about conformity assessments under MDR are not applicable to them. Some of the other notified bodies are not accepting new applications under MDR. Notified bodies that are accepting applications are typically taking several months or more to finish conformity assessments.
The survey suggests it is also common for applicants to wait months to receive authorization to make changes to existing certifications. Half of the surveyed notified bodies are taking one to six months to approve the qualification of a new critical supplier related to an essential COVID-19 device.