News about GMP/cGMP

10.12.2020

MDCG: Q&A clarifies remote audit requirements for Notified Bodies

In December 2020, the Medical Device Coordination Group (MDCG) of the European Commission published a six-page Q&A document on Notified Body audits of medical device manufacturers during the COVID 19 pandemic. 

The document refers to the MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions. In three sections, eleven pairs of questions and answers explain how to deal with quarantine orders and travel restrictions:  

  • Basic information on conducting remote audits 
  • Temporary measures when carrying out on-site inspections 
  • Requirements for remote audits and organizational aspects    

Source: 

MDCG: MDCG 2020-17 Questions and Answers related to MDCG 2020-4 



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