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of medical devices they must include in the instructions for use information allowing the selection of
the corresponding software and accessories.
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Placing on the market:
According to Regulation (EU) 2017/745 – MDR, “Placing on the market” means the first making
available of a device, other than an investigational device, on the Union market;
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According to Regulation (EU) 2017/746 – IVDR, “Placing on the market” means the first making
available of a device, other than a device for performance study, on the Union market;
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Putting into service:
According to Regulation (EU) 2017/745 – MDR, “Putting into service” means the stage at which a
device, other than an investigational device, has been made available to the final user as being ready
for use on the Union market for the first time for its intended purpose;
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According to Regulation (EU) 2017/746 – IVDR, “Putting into service” means the stage at which a
device, other than a device for performance study, has been made available to the final user as being
ready for use on the Union market for the first time for its intended purpose;
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Medical device:
“medical device” means any instrument, apparatus, appliance, software, implant, reagent, material or
other article intended by the manufacturer to be used, alone or in combination, for human beings for
one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or
pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human
body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or
metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as
referred to in Article 1(4) and of those referred to in the first paragraph of this point.
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Active medical device:
“active device” means any device, the operation of which depends on a source of energy other than
that generated by the human body for that purpose, or by gravity, and which acts by changing the
density of or converting that energy. Devices intended to transmit energy, substances or other elements
between an active device and the patient, without any significant change, shall not be deemed to be
active devices. Software shall also be deemed to be an active device;
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Article 32.2(c), Annex I, Chapter III Section 23.4(f), Annex II Section 1.1(h) of Regulation (EU) 2017/745 – MDRArticle
29.2(c) and Annex II Section 1.1(m) of Regulation (EU) 2017/746 – IVDR
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Article 2(28) of Regulation (EU) 2017/745 – MDR
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Article 2(21) of Regulation (EU) 2017/746 – IVDR
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Article 2(29) of Regulation (EU) 2017/745 – MDR
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Article 2(22) of Regulation (EU) 2017/746 – IVDR
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Article 2(1) of Regulation (EU) 2017/745 – MDR
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Article 2(4) of Regulation (EU) 2017/745 – MDR