CER - Literature search strategy and PMV data Timeline - MEDDEV 2.7.1/ Rev 4

J

Jnks_Meddev

#1
Does MEDDEV 2.7.1/ Rev 4 mention CER's anywhere?

1) That depending on the classification of the device the CER's should be updated as following-
Class I - 5 years​
Class II - 2 years​
Class III - Every year​
2) Also the timeline for literature search strategy and PMV data should be good for 5 years and the data should be upto recent (upto 6 months old) of the CER completion timeline?

Thanks!
 
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Marcelo

Inactive Registered Visitor
#2
I'm not sure I understand your questions.

The CER is mentioned a lot of times in the MEDDEV.

Related to updating, 6.2.3.Updating the clinical evaluation deals with that.

2) There's no specificity like you mentioned on the requirements for clinical data.
 
J

Jnks_Meddev

#3
Thanks for responding. Our company policy had these timeline in our SOP and I couldn't find it mentioned in MEDDEV rev4 anywhere so asked.

Thanks!
 
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