Jan 12, 2016

A recent survey of European Notified Bodies (NBs) shows that these organizations issued fewer CE Mark certifications for medical devices between 2011 and 2014 than in 2010.

Although 2010 is the year the PIP case shocked the world and drove increased scrutiny of NBs, it is not possible to find a direct link between that case and the decreasing numbers in certificates.

Fewer new CE Mark certifications

The survey of 25 NBs operating in Europe found that new CE Mark certifications totaled 4,535 in 2014, down from 5,061 in 2013. Although both figures are higher than in 2012, when 3,120 new certifications were issues, all three years saw considerably fewer new certifications compared to 2010, when NBs reported 6,993 new CE Mark certificates. Based on these data alone, however, it is not possible to establish why fewer certificates are being issued.

A major increase in certification withdrawals

Over the same four-year period, NBs report that the number of CE Mark certificate withdrawals in Europe has steeply increased. In 2010, only 244 certificates were withdrawn from the European market; by 2012, that number shot up to 915 withdrawals, and increased even further to 1,058 by 2014.

Why such dramatic increases? The Team NB survey cited several reasons for certificate withdrawals in 2014: client cancellations, non-compliance issues, refusals to undergo audits, mergers and acquisitions among clients, and major nonconformities, for example. But the survey does not indicate which issues occurred how often—have NBs stepped up their scrutiny of clients’ quality systems and found more nonconformities than in prior years, for instance, or were merger and acquisition activities more of a factor in these certification withdrawals?

“Despite the lack of specific data breakdowns, there could be two major reasons for the increased number of withdrawn certificates,” says Ronald Boumans, Senior Global Regulatory Consultant and a former senior inspector at the Dutch Healthcare Inspectorate.

“First are new EU requirements for unannounced audits by NBs at medical device manufacturing facilities, and second is increased scrutiny of clients’ Technical Files or Design Dossiers.”

Furthermore, decreases in new certifications and increases in certificate withdrawals may point to a trend of fewer high-risk medical devices entering the European market.

“A reason may be that manufacturers anticipate stricter levels of review than before, and consequently would rather refrain from submitting until they have upgraded their own data,” explains Jaap Laufer, Vice President of Clinical and Regulatory Affairs at Emergo.

“Whether this could result in delayed or reduced introductions of novel, higher-risk products on the EU market remains to be seen,” Laufer adds.

Most certification holders outside the EU

The Team NB survey also sheds light on how CE Mark holders are distributed in and outside Europe. The 25 participating NBs collectively reported having 31,513 medical device clients in 2014. One third of those clients (33%) were based in the EU, while two thirds (67%) were based elsewhere.

Obviously, these percentages illustrate the appeal of the European medical device market for foreign manufacturers, but now that NBs are required to meet more rigorous auditing and certification obligations—and with new European legislation on medical device regulations coming—it will be interesting to see how, if at all, those percentages of domestic versus foreign CE Mark holders changes.


  • Stewart Eisenhart