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Glossary

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
Search for glossary terms (regular expression allowed)
Term Main definition
Federal Institute for Drugs and Medical Devices
field safety corrective action
A field safety corrective action means a corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
field safety notice
A field safety notice means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.