Demonstration of compliance with general safety and performance requirements must be based on clinical data providing sufficient clinical evidence. The manufacturer must specify and justify the level of clinical evidence required for the device under evaluation.
For legacy devices, MDCG 2020-6 provides guidance to manufacturers on the level of evidence required and accepted for these devices. This guide introduces a strategic route for legacy devices based on a well-known and stable technology, referred to in the text as Well Established Technologies (WET).
What is allowed when using this approach? When and how to apply it? What are the pitfalls to avoid? GMED answers these questions in this latest edition of its newsletter.