Thanks, I wasn't aware there was a more targeted review for medical devices, and updated my comment with a note to that effect.
However it does not seem comparable to a fairly rigorous FDA double-blind experimental process requirements, it only requires the manufacturer to provide a clinical evaluation that appears to be just a little more than a literature review [0][1]
However it does not seem comparable to a fairly rigorous FDA double-blind experimental process requirements, it only requires the manufacturer to provide a clinical evaluation that appears to be just a little more than a literature review [0][1]
[0]https://www.emergobyul.com/services/europe/ce-certification
[1]https://www.emergobyul.com/sites/default/files/eu-meddev-2_7...