请大家仔细研究一下证书其内容:“Verification of the presence of the Technical Files in regards of the Medical Devices Directive…” 意思是此证书证明了机构复核过该企业已经按照医疗器械法规要求来准备技术文档。
“This document has been issued on voluntary basis and not as NB…” 意思是此证书是自愿性出具,不代表我以公告机构名义来执行了此事。
“…declares that the only scope of the assessment is to verify the existence of the declaration issued by the manufacturer or an applicant under its own responsibilities”意思是此证书只是从他们的角度核实了制造商或申请人根据其本身的责任所发出的符合性声明是存在的。
因此,这类所谓的证书不是真正意义上由有授权的公告机构出具的CE证书。所以请大家务必擦亮眼睛鉴别真伪,不要被投机分子钻了空子。
(来源:中国国际商会)