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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
Suche nach Begriffen
Begriff Definition
data monitoring committee - DMC

Independent committee that may be established by the sponsor to assess, at intervals, the progress of the clinical investigation, the safety data or the critical performance endpoints and to recommend the sponsor whether to continue, suspend, modify, or stop the clinical investigation. Examples of DMCs are “data safety monitoring board (DSMB)” or “data safety monitoring committee (DSMC)”.

A deviation is an instance(s) of failure to follow, intentionally or unintentionally, the requirements of the CIP.
device deficiency
A device deficiency is described by an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.