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.
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
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to the use of cookies.