Changes On CE Marking Medical Devices

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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