To Identify the Applicable MDD Directive - Prepared blood smear

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dgrainger

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#12
Hi,
Have you looked at MEDDEV 2.14/1: GUIDELINES ON MEDICAL DEVICES IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES?
Section 1.4 looks at Products for general laboratory use.
 
R

Rezzi

#14
From what I read:
- The device is not an IVD
- Is not LVD except for the Power supply which falls in the LVD scope.
- EMC directive->yes (I Think it is)
- General Product Safety directive ->Yes
 
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