CE certificates up nearly 50% in 2019 in anticipation of MDR
In its annual sector survey, the European notified body group Team-NB found a nearly 50% uptick in the number of new CE certificates issued in 2019 as medical device makers rushed to obtain the certificates before the application of the EU Medical Device Regulation (MDR).While the MDR is now officially delayed by one year, companies planning for the transition in 2019 were braced for the regulation to take effect later this month. (RELATED: MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020).
According to the survey, there were 7,419 new CE certificates issued by 23 notified bodies in 2019 compared to 4,992 issued in 2018, a 49% increase and the highest number issued in a single year since 2010.
“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,” Team-NB says.
At the same time, the number of valid CE certificates declined by 2% to 18,082 certificates, continuing a trend that began in 2015.
The number of withdrawn certificates decreased by 21%, which Team-NB says could be a strategic move by manufacturers “to maintain devices under current [Medical Device Directive] MDD legislation.”
The survey found a similar breakdown compared to previous years in terms of the share of issued certificates for medical devices, in vitro diagnostics (IVDs) and active implantable medical devices, with 88% of certificates going to medical devices, 9% to IVDs and 3% to active implantable devices. This represents a slight shift in share away from medical devices to IVDs and active implantable devices.
Team-NB also observed a 1% increase in the number of valid certificates against ISO 13485, the international standard for medical device quality management systems. The 1% increase represents a leveling off after declines in 2017 and 2018. Team-NB explains that the number of ISO 13485 certificates remains higher than the number of CE certificates as there are suppliers and distributors who require the certificate as well.
Additionally, Team-NB reports that notified bodies continued to see growth in staffing for the seventh straight year. However, Team-NB notes that the 5% increase over 2018 was less than the 29% growth notified bodies had hoped for based on an earlier survey.
“The small increase in number of employees in comparison with the wishes of notified bodies is mainly related to the difficulties to find people with the requested competencies on the market,” Team-NB says.
Team-NB