Fresh approach for ISO 14155 – International standard for the Clinical Investigation of Medical Devices

A revised version of  the clinical evaluation standard ISO 14155, the international standard for the clinical investigation of medical devices was released earlier this year, and sees a number of updates and changes to the standard. The new standard combines the previous two standards of ISO14155 (Part 1 and 2) into one and has been reformed to level the playing field for clinical investigations conducted around the world – both economically and ethically.

ISO 14155 is not as well recognised as other ISO standards, with Japan and the U.S FDA failing to accept the old standard.  It has been argued that the standard lacks essential details and content, which are challenging to include in a document that needs to be flexible enough to pertain to clinical evaluations conducted all over the world under different conditions. However, the rewrite has been harmonised with ICH GCPs where possible while still remaining device-specific. The new approach deals with clinical research from a project management perspective, with the inclusion of sufficient narrative to teach a sponsor how to conduct a clinical investigation.