The long awaited revision to the ISO 14155 standard has finally been released. On February 1, 2011, the International Organization for Standardization (ISO) adopted and published the revised version of the standard, ISO 14155:2011. This affects all medical device manufacturers and is now the standard of reference for conducting medical device clinical studies in the United States, Japan and other countries.
It is important for Medical Device Manufacturers to use this standard to demonstrate compliance with EU requirements for clinical investigations detailed in the medical device directives. ISO 14155:2011 is a single document (the former standard was divided into two parts) and is twice as long as the previous version. The document now includes nine clauses (instead of 15 in the previous version) and eight annexes instead of four in the 2003 version. Worthy of note is also the fact that new requirements have been added to the standard: they deal for the most part with sponsor responsibilities, informed consent for vulnerable subjects, Ethics Committees, study monitoring, electronic data management and risk management.
Download your complementary article: ISO 14155:2011: A First Look now and learn what is now accepted as Good Clinical Practices, what has changed from the last version, and what you need to do to maintain compliance with this important standard.