A new survey conducted by The European Association for Medical Devices of Notified Bodies (Team NB) has found a drop in total number of CE Mark certificates issued from 2010 to 2012.
The 2012 survey queried 28 Notified Bodies compared to 19 in a previous survey conducted in 2010.
The number of new CE Mark certificates totaled 3120 in 2012, according to Team NB’s findings, falling considerably from about 7000 certificates issued in 2010. Team NB attributes this decrease partially to the reclassification of many orthopedic implant devices in 2010.
Although the vast majority of new CE Marking certificates continue to fall under the Medical Device Directive (MDD), the survey notes certificates under both the In Vitro Diagnostic Directive (IVDD) and Active Implantable Medical Device Directive (AIMDD) are increasing. The number of MDD CE Mark certificates fell from 91% of all certificates issued in 2010 to 84% in 2012; IVDD-related certificates increased from six percent in 2010 to nine percent in 2012, while AIMDD-related certificates grew from three to seven percent during the same period.
Most dramatically, the number of CE Mark certificate withdrawals appears to have quadrupled between 2010 and 2012 due to noncompliance, audit refusals, major nonconformities and related issues. More than 900 certification withdrawals occurred in 2012, up from only about 250 in 2010. This major increase could be due partly to the greater number of respondents in last year’s survey, but also to more vigorous Notified Body activity ahead of new European medical device and IVD legislation that could mandate more aggressive NB oversight of their clients’ compliance efforts.
Although the survey’s results should be taken with a grain of salt given the greater number of NB participants compared to 2010, they do suggest either that more medical device CE Mark certification applications are not passing muster, or that NBs are taking a more assertive role in the EU market.