Ec certificate: An EC certificate (not CE certificate

An EC certificate (not CE certificate ) is one of the requirements that must be met before CE marking a class 2a or 2b device. It's issued by a Notified body upon application (and audit). Hi All, We have an ISO 13485 certificate for sub-component manufacturing issued by a notified body (A; Registrar in this case), whereas the FQA and EC certificate for class III device is issued by another notified body (B) for the finished device. The FQA contains the sub-component... The DoC is issued for all device classes (I,IIa/b,III) but your Design Exam Certificate is issued to Class III devices alone. Some health authorities value a design exam certificate more than a Declaration of Conformity because it is a an official certificate from the NB. 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 ...