RUO (Research Use Only - Laboratory Instrument) CE Marking Requirements

D

divyaganapathy

#1
If a product (Lab instrument) is used for research purpose and not for any clinical decision, how do we approach for CE marking? which directive it will fall under Medical device or IVD or Machinary??
 
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pkost

Trusted Information Resource
#2
Hi,

You appear to be posting in the US medical device regulations forum which I should clarify is not related to the EU CE marking regulations.

The EU defines a medical device as
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
A device to be used for research lab only and not in a clinical setting cannot be classed as a medical device as it is not used for diagnostic and/or therapeutic purposes, therefore the medical device directive and IVDD do not apply.

I cannot comment not the machinery directive without having more information available


If your device can be used in a clinical setting and can meet the definition of a medical device then you should make efforts to ensure that the device is not used for this purpose otherwise you could run into trouble.
 

bio_subbu

Super Moderator
#4
If a product (Lab instrument) is used for research purpose and not for any clinical decision, how do we approach for CE marking? which directive it will fall under Medical device or IVD or Machinary??
Refer European Commission's guidance document on medical devices "MEDDEV. 2.14/2 rev.1" IVD GUIDANCE: Research Use Only products A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES.
 

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