Do I need to make a separate application to obtain a Full Quality cert/ separate audit or is it part of the CE mark application? Your CE certificate ( EC certificate ) is the full quality assurance certificate . The "Annex II" and "full quality assurance" will appear on the certificate . Dear all Our sales people are facing some stupid questions from customers. As you know the certificate issued by NBs for CE marking in English will always have the title as " EC Certificate " Instigated by some of the competitors our customers are saying that this is not CE certificate this is... CE认证和MDR是欧洲法律体系下与 产品合规性 和 医疗器械 相关的 两个不同概念。 CE认证是一种自我声明的标志，表示产品符合欧洲经济区（EEA）的相关法规和标准，可以在该区域自由流通。CE认证适用于大多数非医疗器械产品，例如电子设备、机械设备、玩具等。获得CE认证需要产品制造商对其产品进行符合性评估，并确保符合适用的欧洲标准和指令要求。 而MDR是一项新的 ... That being said is it an EC Certificate or a CE certificate ? Additionally what does the EC stand for in EC certificate . I have looked in the directives and on BSI's website, but all I find is that for a CE mark, "CE" stands for the french words Conformité Eurponéene.
