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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