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Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms.
First implemented by Team-NB in early 2013, the Code of Conduct’s version 3.2 makes more explicit processes and procedures Notified Bodies should follow during CE Marking audits and certifications; another update, version 4.0, is already planned for the near future.
Among the changes in version 3.2 of the code are requirements for compliance with specific EU Medical Device Directive mandates rather than core principles; adjusted frequency requirements for unannounced audits of high-risk devices; and changes to sampling requirements of technical file reviews to apply only to Class IIa and IIb devices.
Team-NB describes these changes as minor, but also indicates more important issues to be addressed in version 4.0 of the code, including minimum review timeframes for technical files, auditor qualifications and developing criteria for technical reviews and training.
Following implementation of the Code of Conduct, European medical device market observers and participants questioned whether new requirements would shake up the Notified Body sector.
According to information Team-NB included in its announcement of the code’s latest version, there has been a slight drop in the number of the association’s members since 2012. Since plans for the Code of Conduct were first announced, Team-NB membership fell from 35 in 2012 to 29 in 2013; that number fell again to 26 in 2014.
(Emergo Group)
Tags: Emergo Group, CE Mark, European Association for Medical Devices of Notified Bodies