ISO 14155 Revisions to Substantially Impact Clinical Investigations
The International Organization for Standards (ISO) recently published a revision of its ISO 14155 rule governing clinical trials for medical devices, ISO 14155:2011, and manufacturers will have several new requirements to address in order to comply. (An overview of the revised standard is available from Excel Translations.) ISO 14155:2011 follows ISO 14155:2003 and ISO 14155:2009, European standards applied to medical device clinical investigations. The new standard is entitled Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practices, and applies globally to all medical device manufacturers conducting clinical studies. The revised standard’s new requirements pertain primarily to sponsor responsibilities, informed consent rules, ethics committees, study monitoring and data and risk management. Risk management features particularly strongly in ISO 14155:2011, which frequently references another medical device risk management standard, ISO 14971. Once ISO 14155:2011 is published in the Official Journal of the European Union, mandatory compliance will go into effect. Each ISO member nation will have the opportunity to modify ISO 14155:2011 before adopting the standard—thus, actual requirements may vary from market to market. As such, manufacturers should pay close attention to ISO 14155:2011 requirements particular to the countries in which they plan to conduct clinical investigations.