CE Marking for Research Instruments - Small Company - Class II Medical Device

rthompson

Starting to get Involved
#1
Greetings Covers - We are a small company that both manufactures medical devices (Class IIa) and instruments for neuroscience research. We currently have a CE certificate for our medical devices and are looking to achieve CE certification for the research instruments as well. The instruments are not considered medical devices so I'm struggling to understand how we will go about achieving CE certification? What standards apply to non-medical devices? Does anyone have experience with a similar scenario?
Much thanks in advance for any suggestions.
 
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Al Rosen

Staff member
Super Moderator
#2
Re: CE Marking for Research Instruments

Greetings Covers - We are a small company that both manufactures medical devices (Class IIa) and instruments for neuroscience research. We currently have a CE certificate for our medical devices and are looking to achieve CE certification for the research instruments as well. The instruments are not considered medical devices so I'm struggling to understand how we will go about achieving CE certification? What standards apply to non-medical devices? Does anyone have experience with a similar scenario?
Much thanks in advance for any suggestions.
Can you provide a little more detail about your instruments? Otherwise, look at the list of directives to see which one(s) would apply to your instruments.
 
R

Roland Cooke

#3
It really comes down to what you mean by "research".

If these are laboratory tools for laboratory use only, they may well not fall under any Directive (although Machinery, Low Voltage etc may still apply).

If they are medical devices - or accessories to medical devices - that will be used on humans, even if in a clinical research capacity, they must be CE-marked under the relevant Medical Device Directive.
 
J

JSambrook

#4
Understanding that your comment is many years old and things may well have changed since it was written, I think that if a device falls within the scope of any Directive, it must carry the CE Marking in order to be legally placed on the market.

I welcome any corrections if this is not correct.
 
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