Determining if an Insulin Pen Testing Machine is a Medical Device?

#1
Dear all,

My company is developing a machine that is used to test the Sanofi Insulin Pen function to know if the pen works or not.
The mechanism of our machine is to use the torque sensor to test the dial knob of the insulin pen.

Our product has a similar mechanism as the tester from Zwick Roell as the Youtube link attached:

I have a question that if our machine is determined as a Medical Device or not, since it only tests the function of the Insulin Pen but not to impact directly to human?

I am looking forward to seeing you reply.

Sincerely yours,
Matthew
 
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chris1price

Trusted Information Resource
#2
No, it is not appear to meet the definition of a medical device (see below), unless....... your product is supplied to an end user (not the manufacturer) to allow them to test the Insulin Pen before use.

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;

(b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
 
#4
No, it is not appear to meet the definition of a medical device (see below), unless....... your product is supplied to an end user (not the manufacturer) to allow them to test the Insulin Pen before use.

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;

(b) ‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;

Dear Chris1price,

I really appreciate your answer to consolidate our confidence in CE affixing process for our machine. Could you please support to answer another question.

As our machine is not a medical device but it is still applied to test a medical device (in this case the Insulin Pen), does our machine need any critical or important requirements except the harmonized standards regarding the directive LVD, RED, MD, EMC?

Sincerely yours,
Matthew
 

chris1price

Trusted Information Resource
#5
Yes, you would need to comply with the LVD. You probably should do an assessment as to whether you need to comply with the EMC directive, also consider IEC61010.
 
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