The number of CE Mark approvals in 2019 soared by 50% over those recorded the previous year in anticipation of the now-postponed May 26, 2020, deadline for European Union’s Medical Device Regulation (EU-MDR), according to a European notified bodies organization.
The European Association for Medical Devices of Notified Bodies released a report today highlighting its finding. CE Mark approvals were also up by 30% in 2019 from the previous year, the group noted.
“This adds to a significant increase in the workload in these 2 years,” Team NB said in a news release.
“This is surely in line with the wish of industry to renew their certificates against current MDD legislation in order to avoid the need to adapt to the new legislation at short notice.”
The number of CE Mark certificate withdrawals fell by 21% in the same period, possibly as part of
manufacturers’ strategy to maintain devices under current MDD legislation. The number of ISO 13485 certificates stabilized after 3 years of declines.
The survey compiled the data from 23 notified bodies, the same number as in 2018, despite the fact that all UK group members resigned their membership in 2019.
The European Parliament voted April 17, 2020, to postpone implementing MDR as member countries reeled from the early impact of the COVID-19 pandemic.