Handbook recommended lightcycler for IVD

yannis34

Registered
Hi,

Im internship in a company in europe who will start to sell in Europe a test IVR (class C) for patient in hospital, and im wondering if on the handbook, the mention "recommended use lightcycler mark ******* " is a problem when our notifier body will going to examine the technical documentation. Indeed, we know if the clinician use lightcycler other the mark we recommended, the test doesnt work.

Thanks !
 
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