MDR: The Regulation (EU) 2017/745

— What’s the “Medical Device”?

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The EU revised the laws governing medical devices align with the developments of the sector over the last many years.

Now, the following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 (this regulation is MDR):

  • 1998: Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (IVDMD);
  • 1993: Council Directive 93/42/EEC on Medical Devices (MDD);
  • 1990: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD).
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The definition of medical devices in the regulation(EU) 2017/745 is:

‘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.

patient monitors

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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