Notified Body Survey Offers New Data on EU Medical Device Certificates
Posted 24 June 2019 | By
Findings from a recent survey of notified bodies (NBs) for medical devices and in vitro
diagnostics (IVDs) indicate fluctuation in the numbers of certificates in 2018 versus prior years.
The European Association for Medical Devices of Notified Bodies—Team-NB—surveyed its 23 members at the end of 2018 and the results illustrate show how companies are preparing for the EU’s medical device and in vitro
diagnostic regulations (MDR/IVDR).
Last year saw an increase of nearly 30% in the number of new certificates issued by member NBs—totaling 4,992 certificates—after four years of decline in these total numbers. This is “surely in line with the anticipation of industry in the renewal of their certificates against” the EU’s medical device directive “in order to avoid the uncertainties of the future,” said Team-NB.
MDR provides a grace period so certificates can remain valid through 2024, although that grace period does not apply to some classes of devices. Certificate renewals come in anticipation of an NB shortage under MDR as well.
There was a 6% decrease in the number of valid certificates at the end of 2018, with just 18,449 certificates in total versus 19,775 certificates at the end of 2017. The total number of withdrawn certificates grew by 17% to 1,220 certificates in 2018, up from 1,043 certificates in total the year prior. Reasons NBs’ clients cited for withdrawing certificates include financial issues, an NB change and Brexit, among others.
The fluctuation in the number of valid and withdrawn certifications coincides with the impact of MDR/IVDR on product portfolios. But a lack of EU-wide coordination
on device portfolios could create EU-wide supply bottlenecks amid the transition to MDR/IVDR.