Dive Brief:

• Notified bodies reported a 49% year-on-year increase in the issuance of new CE mark certificates, continuing the upward trend that began in 2018.

• Trade group Team-NB on Tuesday presented data from 23 notified bodies that showed 2019 was the busiest year for new CE mark certificates in at least a decade.

• Team-NB attributed the surge in new certificates to a push by industry to get CE marks in place under the outgoing Medical Device Directive, buying themselves time to move to the new rules. That, of course, came before the EU moved to delay the new Medical Device Regulation by a year amid the COVID-19 pandemic.

Dive Insight:

Team-NB presented the results alongside the findings of earlier versions of the survey dating back to 2010. The comparison shows 2019 to be an outlier in some important regards.

According to the survey, notified bodies issued 7,419 new CE certificates in 2019. That represents a 49% increase over the prior year, and a 93% jump compared to 2018. For most of the past decade, the annual number of new CE certificates was below 5,000, only breaching that figure in 2010 and, barely, in 2013.

Prior to the COVID-19 pandemic persuading the EU to delay the incoming MDR that had been set to go into effect May 26, 2020, the entities were likely scrambling before that deadline.

“This is surely in line with the wish of industry to renew their certificates against current [Medical Devices Directive] legislation in order to avoid the need to adapt to the new legislation at short notice,” the trade group wrote. 

Other aspects of the data trends in the survey were also likely due to the looming go-live start date, including the decline in the number of CE certificates withdrawn, the group said.

In 2019, manufacturers withdrew 957 certificates, down 21% on 2018. Fewer certificates were pulled in 2019 than in any year since 2013. Manufacturers withdrew 1,881 certificates in 2016.

Reasons for withdrawals shared with Team-NB through the survey include financial issues, the cost of the notified body, as well as mergers and acquisitions. 

Notified bodies continued to grow their collective headcount in 2019, making it the seventh year in a row that the number of full time employees at Team-NB members rose. However, the 5% rise in headcount is well below the rate of increase previously targeted by notified bodies.

A February 2019 survey run by Team-NB showed its members planned to grow their staffs by 29% last year. To Team-NB, the difference between the actual and targeted figures relates to access to talent.

“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. It is a real problem the notified [bodies] are facing,” Team-NB wrote.

Team-NB’s comments follow a decade in which notified bodies grew significantly. In 2010, Team-NB members employed 45 full-time staff, on average. By 2019, the figure had risen to 119. The increase covers a period in which European authorities sought to raise the standards of devices sold in the region.