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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
A patient describes an individual who participates in a clinical investigation, either as a recipient of the device under investigation or as a control.
Synonyme - subject
Paul-Ehrlich-Institute - PEI
The Paul-Ehrlich-Institute (PEI) is a competent authority and responsible for performance evaluations of high risk in vitro diagnostic agents.
project manager
A project manager is an individual or body with authority, accountability and responsibility for managing a project to achieve specific objectives.