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EU MDR CAPA - GAP Assessment on CAPA SOPs

Seekingknowledgee

Starting to get Involved
#1
Hi Folks,

I am supposed to do a GAP Assessment on CAPA SOPs that are present in my company. I have gone through the EU MDR for CAPA content. But I am really not able to get solid information on that. Is there someone who can help me on that? Have CAPA regulations in MDR changed compared to MDD? Any specific Annex or Chapter that focuses on CAPAs in the mdr?

Thank you in advance
 
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shimonv

Trusted Information Resource
#2
MDR has no specific provision for CAPA. Auditors may expect to see more clinical data where necessary, but the process remains the same.
 
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