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Glossar

The glossary explains some important terms used in clinical research and clinical trials. In addition to our own knowledge and expertise, the following sources were used to define the terms:

  • Medical Device Regulation (MDR) 2017/745
  • Medical Device Directive (MDD; Richtlinie 93/42/EWG)
  • Medical Device Act (Medizinproduktegesetz; MPG)
  • MEDDEV 2.7/1 revision 4 (MEDical DEVices)
  • ISO 14155:2020
  • ICH-GCP
Suche nach Begriffen
Begriff Definition
medical device - MD

A medical device can be any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used on human beings for the purpose of

a) diagnosis, prevention, monitoring, treatment or alleviation of disease,

b) diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,

c) investigation, replacement or modification of the anatomy or of a physiological process,

d) 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.