4 ms·
Will this work outside of US or does it need to get approved by other orgs, like whatever is EUs FDA?
by nextlevelwizard 2y ago
Will this work outside of US or does it need to get approved by other orgs, like whatever is EUs FDA?
- brandonb 2y agoThey announced they're targeting 150 countries, so there will likely be CE-mark approval coming (this is the EU equivalent of the FDA).
- dns_snek 2y agoCE marks aren't an equivalent to an FDA approval process, they're self-certified with no real oversight. > By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. > Please note that a CE marking does not indicate that a product have been approved as safe by the EU or by another authority. It does not indicate the origin of a product either. https://single-market-economy.ec.europa.eu/single-market/ce-marking_en https://single-market-economy.ec.europa.eu/single-market/ce-...
- adw 2y agoThe equivalent is the EMA.
- brandonb 2y agoI'm not an expert on European law, but the requirements listed here for a CE mark indicate that the EMA reviews the safety and performance of the device and audits the manufacturer's quality systems, similar to the FDA: https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices https://www.ema.europa.eu/en/human-regulatory-overview/medic... CE marks for other categories may well be self-certified. I suppose I could have been a bit more precise in my terminology, and said the EMA (who gives the CE mark) is the equivalent of the FDA in Europe.