EN ISO 14155 definition

EN ISO 14155 means EN ISO 14155: Parts 1 and 2: the harmonised International and European standard entitled “Clinical investigation of medical devices for human subjects” which provides voluntary guidance on good clinical practice for medical device clinical investigations.
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Examples of EN ISO 14155 in a sentence

  • This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.” As a general principle, “the rights, safety and wellbeing of clinical investigation subjects shall be protected consistent with the ethical principles laid down in the Declaration of Helsinki” (EN ISO 14155).

  • It is NOT intended that it will reproduce EN ISO 14155 or ICH GCP, but it will summarise for the benefit of staff of all parties administering the investigation site, issues over which the NHS body will liaise with the CRO.

  • Ultimately, under EN ISO 14155 or ICH GCP, the sponsor is accountable for the execution of sponsor duties, even if they are delegated to a CRO.

  • Guidance is available in MedDev 2.7.1, GHTF SG5 N2R8 and EN ISO 14155.

  • Clinical investigations, must be conducted in adherence with Good Clinical Practice (GCP), where EN ISO 14155 is the standard for the GCP of medical device clinical investigations (see ISO 11980:2012 below for more detailed guidance on CI of contact lenses) [30].

  • In the model CIA that is a blank template where the sponsor and CRO will set out the sponsor’s investigation-related duties and functions under EN ISO 14155 or ICH GCP that will be performed by the CRO.

  • The applicable rules on good clinical practice in clinical trials with medical devices were incorporated into Swiss legisla- tion by way of reference to annexes VIII and X to the Direc- tive 93/42/EEC, annexes 6 and 7 to the Directive 90/385/ EEC, and Article 42 of the Guidelines on Medical Devices (MEDDEV 2.7/3) of December 2010, as well as in EN ISO 14155.

  • Monitoring functions will be performed in compliance with Good Clinical Practices, EN ISO 14155, and as outlined in 21CRF§812.43(d) and 21CRF§812.46.

  • Dr.AB, Department of………., Medical University of Vienna, Austria _________________ ___________ Signature Date Sponsor/OEL (MPG § 3) Medical University of Vienna, Austria or company _________________ ___________ Signature Date Representative of CRO (EN ISO 14155 ) Name: ………….

  • Clinical investigations not in compliance with applicable ethical standards, medical device standards (for example EN ISO 14155 or comparable standards) or regulations should not be used for demonstration of performance and/or safety of the device.

Related to EN ISO 14155

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