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07. June 2019

MDCG 2019-6 published

The latest MDCG Guidance includes "Questions and Answers, relating to Notified Bodies" for the application of the MDR.

 

Although the focus as identified in the title are the Notified Bodies some interesting information for the manufacturers can be found as well.

Just to name two topics:

 

  • Auditing of subcontractors
  • OBL situation under the MDR
tagPlaceholderTags: MDR, (EU) 2017/745, medical device, Guidance, medical, MDCG

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