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ISO 20916:2019 published

  • Posted by: inetika
  • Category: GLOBAL NEWS

ISO 20916:2019, ‘In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice’, defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. Further details are available from the ISO website.

The foreword to the standard explains that it identifies the principles that underpin clinical performance studies and specifies general requirements intended to:

  • ensure the conduct of the clinical performance study will lead to reliable and robust study results,
  • define the responsibilities of the sponsor and principal investigator,
  • assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
  • protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.

It goes on the explain that the purpose of such studies is to assess the ability of an IVD medical device, in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD in question are adequately addressed by the clinical performance study.

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