The MDCG updated its Interpretation document on Article 54 (2)b of the MDR that exempts certain already marketed class III and class II devices from otherwise necessary clinical evaluation consultation procedure under Article 54(1).
Two pages were added to the document and require from the manufacturer to submit to the Notified Body with its application:
- a statement that it has marketed the device in question for the same intended purpose under the relevant Directive,
- copy of the . . .
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