Notified Bodies will audit and supervise the manufacturers differently in order to obtain CE marking certification from 2014.
Two documents published by the EU Commission install a tighter regime of audits and technical documentation assessment on manufacturers of medical devices. The two Commission documents are:
- Commission Implementing Regulation (EU) No 920/2013 on the designation and the supervision of Notified Bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.
- Commission Recommendation on the audits and assessments performed by Notified Bodies in the field of medical devices 2013/473/EU.
How this rules will effectively change the way manufacturers will implement CE marking is still to be known
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