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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 regu
by becurious 6y ago
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.
- Unibod 6y agoJust 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]
- wlonkly 6y agoIf 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.
- lgats 6y agoLink for those curious https://en.m.wikipedia.org/wiki/CE_marking#China_Export https://en.m.wikipedia.org/wiki/CE_marking#China_Export Though I believe neuromod is advertising CE compliance not ‘China Export’
- ineedasername 6y agoThanks, 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 https://www.emergobyul.com/services/europe/ce-certification [1]https://www.emergobyul.com/sites/default/files/eu-meddev-2_7_1-clinical-evaluation-guide-for-manufacturers-and-nb.pdf https://www.emergobyul.com/sites/default/files/eu-meddev-2_7...