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Commission publishes notified bodies Q&A

  • Posted by: inetika
  • Category: GLOBAL NEWS

The Medical Device Coordination Group has published a Q&A document on requirements for notified bodies. The issues covered have been identified in the context of joint assessments, and the document may be updated from time to time as new issues are identified.

The Q&As cover technical aspects relating to notified bodies’ operations, such as “Are CABs obliged to follow guidance endorsed by the Medical Devices Coordination Group?”, and “What should be the criteria for auditing suppliers and subcontractors?”

The questions are grouped into five sections:

  • Organisational and general requirements
  • Quality management system
  • Resource requirements
  • Process requirements
  • Others
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