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According to a European Commission survey, notified bodies are taking up to a year to complete conformity assessments on COVID-19 medical devices and diagnostic.

The survey, conducted in May, polled 37 notified bodies and found that 55 per cent expected to spend between six months and a year processing applications for some Class IIb devices which are essential to COVID-19 response.

The Commission’s survey came after it called on notified bodies to prioritise COVID-19 conformity assessments, raising concerns that the process could take several months. The Commission also said it would share information regarding notified bodies’ availability and capacity.

In the survey, notified bodies were asked to provide their average times for completing different activities related to the novel coronavirus.

Most notified bodies report taking between one and three months to complete conformity assessments on Class I devices under the outgoing Medical Devices Directive (MDD), with one-third saying they were taking in excess of three months on Class I devices.

One-third also said they were either not accepting new applications for essential COVID-19 devices under MDD or have a waiting list longer than one month.

However, higher-risk devices are taking longer to process, with around half of those polled spending between three and six months on conformity assessments for Class II devices and waits between six months and one year common for Class IIb devices.

The European 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.”

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