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How frequent to conduct Clinical / Performance Evaluation?

#1
Hello everyone,

I'm new to the cove, as well as QA & RA, nice to meet you guys =].

My company designed and manufactured IVD kit and instrument, have been selling for a while and nothing has changed, while the clinical performance data and the referenced documents are dated back in 1999-2013....

May I know how frequent do we need to conduct clinical / performance evaluation(s)? provided that nothing has been changed, including design, manufacturing process, etc. since 2013....

Thank you everyone!!
 

FoGia

Involved In Discussions
#4
The methods of clinical evaluation don't't apply to IVD, so your clinical evaluation would only cover the instrument. Provided that you have already sufficient clinical evidence, that your product is established and that it is low risk your update frequency can be lower (look into the MEDDEV 2.7/1 rev 4 for some guidance).
 
#5
Throughout the year, post market surveillance (PMS) is constant and the requirement is a report once a year
Anything from the PMS may end up in the clinical evaluation & risk management file and the frequency is as necessary
 
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