The Public Health and Safety Organization

Clinical Evidence for Medical Devices and IVDs

A Comparison of Requirements in Brazil and the EU

The requirements for demonstration of safety and efficacy/performance by providing clinical evidence have increased in recent years. With the application of Regulations (EU) 2017/745 and 2017/746, manufacturers are expected not just to prepare a report but to implement a full process for the assessment of clinical data. Read our latest article by Magdalena Brendel Rizzo and Kivia Pontes de Oliveira published in the Journal of Medical Device Regulation.

health sciences

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