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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
technical documentation - TD
Technical documentation represents the entirety of the documents describing a device. The manufacturer supplies information materials, device's design, development, the instruction for use and the regulatory status within target markets. Technical documentation is require for the assessment of conformity to th essential requirements and for the approval of a medical device.
Synonyme - technical file
trial master file - TMF
A trial master file (TMF) is the collection of essential documents that is used by sponsors, CROs and investigators/institutions for the management of the trial and by monitors, auditors and inspectors to review and verify whether the sponsor and the investigators/institutions have conducted the trial in line with the applicable regulatory requirements and the principles and standards of GCP.
Unlike the ISF, the TMF remains by the sponsor.