Medical Writing The Data Economy The value of registry data in the clinical evaluation of medical devices
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Volume 29, Issue 2 - The Data Economy

The value of registry data in the clinical evaluation of medical devices

Abstract

Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess available implant registry data as part of the clinical evaluation process. This new requirement will necessitate a closer collaboration between industry and registries to evaluate the safety and performance of high-risk devices. Medical writers should be aware of existing implant registries, understand what characteristics make a registry suitable to support regulatory requirements, and recognise both the value and the limitations of registries as a source of clinical evidence.

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