Re:Tinnitus Treatment from Neuromod
by becurious on Friday October 16, 2020 @06:31PM
(#24805652)
No, there is CE marking for medical devices in the EU which means it has achieved conformity for the Medical Devices directive. Generally equivalent to FDA regulation.
[ Parent
| on HN ]
Just beware there is an EU CE and Chinese export C E. They are different. I probably can't post a link but the search you need is this: CE eu markings CE china export.
CE is a mark of quality assurance and compliance. C E is not the same.
[edit for spelling]
Link for those curious https://en.m.wikipedia.org/wiki/CE_marking#China_Export
Though I believe neuromod is advertising CE compliance not ‘China Export’
If the space is meant to represent the gap between the C and E, then you have this backwards: the European mark has one letter-width space between the C and E, and the forged mark from China has the C and E right next to each other.
Re:Tinnitus Treatment from Neuromod
by ineedasername on Friday October 16, 2020 @07:02PM
(#24805839)
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]
[0]https://www.emergobyul.com/services/europe/ce-certification
[1]https://www.emergobyul.com/sites/default/files/eu-meddev-2_7...