EC Attestation of conformity.This certificate issued by Notified Body(NB). Download the template Notified Body:https://ec.europa.eu/growth/single-market/goods/building-blocks/notified-bodies_en
tid=98155 EC符合性声明(EC Declaration of Conformity)通常应该包括的内容: /read.php?tid=116090 医疗器械CE认证中的技术文件及常见的误区的讨论: /read.php?tid=117118 MDD指令93/42/eec 基本要求的解释指南 /read.php?tid=128548 法律对CE图案有何要求? 真假CE标记的对比 欧盟对编写标签和说明书的要求: (...
CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content (template) What is a manufacturer? What are the responsibilities of a manufacturer? Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer? Why is CE marking called "European passport...
CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content (template) What is a manufacturer? What are the responsibilities of a manufacturer? Is the Own Brand Labeller or Private Labeller considered as the legalManufacturer?
TSE Certificate of Conformity to Harmonized Documents SPICE Certificate Certificate of Conformity to Common Criteria Cryptographic Modules Certificate E1 Formaldhyde Emmission Certificate Good Manufacturing Practices (GMP) Certificate G Mark CB Test Certificate CCA - NTR Certificate CENELEC KEYMARK Certificate ...
CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content (template) What is a manufacturer? What are the responsibilities of a manufacturer? Is the Own Brand Labeller or Private Labeller considered as the legalManufacturer?
CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content (template) What is a manufacturer? What are the responsibilities of a manufacturer? Is the Own Brand Labeller or Private Labeller considered as the legalManufacturer?
Usability engineering procedure and template Team support and suggestions Review and approval Usability engineering report PHASE 5 5.1 Pre- Clinical (Active, Non-active, Implantable and Software Devices) Identification of Regulatory Requirements Biological Evaluation and Planning and Test Identification...
IR050 NBOG F 2017-6 Preliminary assessment review template (IVDR) 2018 指南 EN 下载 IR051 NBOG F 2017-4 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) 2018 指南 EN 下载 IR052 NBOG F 2017-1 Application form to be subm...
Below is an example template of DoC. (source)Who can be an EU Responsible Person?An EU Responsible Person can be one of the following:The manufacturer or brand, if established in the EU. An importer established in the EU. An authorized representative established in the EU, who is appointed...