A recent survey of European Notified Bodies (NBs) shows that these organisations issued fewer CE Mark certifications for medical devices between 2011 and 2014 than in 2010.
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 In 2010, only 244 certificates were withdrawn from the European market; by 2012, that number shot up to 915 withdrawals, and increased even further to 1,058 by 2014.
There could be two major reasons for the increased number of withdrawn certificates,” says Ronald Boumans, Senior Global Regulatory Consultant and a former senior inspector at the Dutch Healthcare Inspectorate.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.