How is a Medical Device defined in the EU?

G

Gerry

#1
Hi everyone,

How is a ''medical device'' defined in the EU? Is the EU definition of a ''medical device'' the same as the GHTF one? Or is it different? That's my query. Any help would be greatly appreciated.


Thank you.

Gerry
 
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amjadrana

Involved - Posts
#2
According to Medical Device Directive 93/42/EEC the following is the definition :

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.

And the definition of Medical Device according to GHTF document GHTF/SG1/N29R16:2005 is the following:


`Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
a) intended by the manufacturer to be used, alone or in combination, for human beings for
one or more of the specific purpose(s) of:
· diagnosis, prevention, monitoring, treatment or alleviation of disease,
· diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
· investigation, replacement, modification, or support of the anatomy or of a physiological process,
· supporting or sustaining life,
· control of conception,
· disinfection of medical devices,
· providing information for medical or diagnostic purposes by means of in vitro
examination of specimens derived from the human body;
and
b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

There are small differences as these are also in ISO 13485, Canadian Medical devices regulations or FDA definition of Medical devices.
Hope it answers your question.
Amjad Rana
 
G

Gerry

#3
According to Medical Device Directive 93/42/EEC the following is the definition :

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.

And the definition of Medical Device according to GHTF document GHTF/SG1/N29R16:2005 is the following:


`Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
a) intended by the manufacturer to be used, alone or in combination, for human beings for
one or more of the specific purpose(s) of:
· diagnosis, prevention, monitoring, treatment or alleviation of disease,
· diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
· investigation, replacement, modification, or support of the anatomy or of a physiological process,
· supporting or sustaining life,
· control of conception,
· disinfection of medical devices,
· providing information for medical or diagnostic purposes by means of in vitro
examination of specimens derived from the human body;
and
b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

There are small differences as these are also in ISO 13485, Canadian Medical devices regulations or FDA definition of Medical devices.
Hope it answers your question.
Amjad Rana
Thank you, Amjad. I came across sources that seemed to somewhat conflict what I was thinking about the definitions. I wasn't sure if these 2 separate ones are now amalgamated (since the EU directive changes in 2007). I anticipated that the GHTF and EU definition had been harmonized ever since, but obviously not?
 
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