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Updated July 27, 2021

What's the Definition of a Medical Device According to the MDR?

Dr. Oliver Eidel
Getting Started

Question

What’s the definition of a medical device according to the MDR?

Short Answer

Don’t expect a short answer when I’m about to cite regulations.

Long Answer

In the MDR article 2, section 1, it says:

“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.

Is our Software a Medical Device?

Check out this answer on whether your software is a medical device.

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I work as a regulatory consultant for Healthcare software startups. I try to publish all my knowledge here so that startups can certify their medical devices themselves in the future.

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