Procedure for clinical evaluation according to new MDR

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Bhavta

Starting to get Involved
#5
Good morning All, just a quick question, my company is currently in the process of obtaining the CE mark, we have a company registered in the UK. I just need some direction as to were adverse events are reported and the time frames as per EU regulation.

Thanks in advance for your help
 

Philip B

Quite Involved in Discussions
#6
Good morning All, just a quick question, my company is currently in the process of obtaining the CE mark, we have a company registered in the UK. I just need some direction as to were adverse events are reported and the time frames as per EU regulation.

Thanks in advance for your help
You report adverse incidents to the MHRA. Their guidance document on reporting, including timeframes, is here: Medical devices: guidance for manufacturers on vigilance

HTH
 
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