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

[Jnks_Meddev]

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!

 

[Marcelo]

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.

 

[Jnks_Meddev]

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!