CEN/TC 258 - Clinical investigation of medical devices

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.
ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to:
protect human subjects;ensure the scientific conduct of the clinical investigation;assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.
ISO 14155-1:2002
specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device,is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.
ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.

1 Scope
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of EN 540:1993 (TC Res 112/1998) (CC/990121) ++ Contact Mr Vyze ext 850 when processing this project through each stage++TC forecasts updated (TC forecasts updating exercise.sj 00-10-03)++

This European Standard pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment before being placed on the market.   This European Standard does not apply to in vitro diagnostic devices.