Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

We have a system that has console to control the movements of different instruments that are attached to the cart. Console and Cart are 2 different devices but with same intended purpose, classification, rule, etc. Both of these are considered machinery but then one of the requirements of EHSR mentions 'control devices', I could not find the definition of it. I am confused as to just mention Console as a 'control device' as it controls the motion of the instruments attached to the cart. But not sure if I should also mention cart as it also has its own motion. If someone can help me understand and provide the definition of 'control devices' that would be very helpful.

Hi Anon

Basic meaning of "control device" is a thing the user interacts with to control the machinery. It could be buttons, knobs, levers, and more interesting things. For reference you might look at the definitions in ISO 12100 (https://www.iso.org/obp/ui/#iso:std:iso:12100:ed-1:v1:en). There are some examples there of special kinds of control devices that are sometimes used for reducing risks.

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Anne LeBlanc
United States
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Original Message:
Sent: 07-Jan-2022 17:54
From: Anonymous Member
Subject: EU MDR CE Mark Machinery Directive

This message was posted by a user wishing to remain anonymous

Hi All,

We have a system that has console to control the movements of different instruments that are attached to the cart. Console and Cart are 2 different devices but with same intended purpose, classification, rule, etc. Both of these are considered machinery but then one of the requirements of EHSR mentions 'control devices', I could not find the definition of it. I am confused as to just mention Console as a 'control device' as it controls the motion of the instruments attached to the cart. But not sure if I should also mention cart as it also has its own motion. If someone can help me understand and provide the definition of 'control devices' that would be very helpful.