Medical device regulations around the world generally require manufacturers of most types of medical devices to supply data as part of the regulatory review process that supports claims regarding the safety, performance and effectiveness of their devices. For new or novel devices that may not have a predicated device, this data is typically derived from clinical investigations, studies or trials conducted by the manufacturer or an appointed third-party contract research organization (CRO) with specialized expertise in conducting such investigations.
However, the cost of a clinical investigation can run into the millions of dollars and often take a year or more to execute. Further, nuanced differences in regulatory requirements can render the data from a clinical investigation inadmissible or otherwise unacceptable by authorities in a given jurisdiction. These challenges require manufacturers to design and execute medical device clinical investigations that meet threshold requirements for safety and effectiveness while also addressing variations in how regulators define these requirements.
This UL white paper discusses the scope of clinical investigations applicable to medical devices, the role of ISO 14155, Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice (GCP) in the acceptance of clinical data by regulatory authorities. Beginning with an overview of the types of medical devices subject to clinical investigations, the paper next reviews some of the current challenges facing device manufacturers in conducting clinical investigations. Then, the white paper will present a brief history of ISO 14155 and the status of its acceptance by regulatory authorities around the world, before offering a detailed summary of the standard’s key provisions. The paper concludes with some additional considerations for medical device manufacturers in designing clinical investigations that are aligned with regulatory requirements.