Veterinary anesthesia machine

GoSpeedRacer

Registered
Greetings,
We are a manufacturer of a veterinary anesthesia machine and I want to learn what is required to place a CE mark in order to market in the EU?
As this is only to be used on animals will it fall under EU MDR? It is just an low voltage electrical device so would it fall under low voltage directive?
I am trying to asses what steps I can accomplish and what if any outside testing or certifications will be required.
Any help is appreciated.

Speed
 

dgrainger

Trusted Information Resource
The medical device regulations only cover human use so you're going to have to look at the following directives:
Low Voltage directive​
EMC directive​

And possibly:
Machinery directive​
Explosive Atmospheres Directive​
Measuring Instruments​
Pressure vessels directive​
 
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