Intended Use-Class I Self Certified - Intended Use and Indications for Use statements

kunal9218

Starting to get Involved
#1
According to EU MDR, we need a separate Intended Use and Indications for Use statements. My question here is: Does a Class I need an Intended use statement?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
The IFU has to include, regardless of class, the following:
(b) the device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate;
(Annex I s. 23.4)
 
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