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They announced they're targeting 150 countries, so there will likely be CE-mark approval coming (this is the EU equivalent of the FDA).
by brandonb 2y ago
They 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.