Relevant technical documents of products with CE labels are subject to inspection at any time
EU law requires that after CE labeled products are put on the European market, their technical Files must be stored in the EU for inspection by supervisory bodies at any time. If the contents contained in the technical documents change, the technical documents should also be updated in time.
Technical documents should normally include the following:
A. Name, trade name and address of the manufacturer (EU Authorized Representative (EU Authorized Agent) AR.
B. Model number of the product.
C. Instructions for the use of products.
D. Safety Design document (Key Structural Diagram, which can reflect creeping distance, clearance, insulation layer number and thickness).
E. Technical conditions of products (or enterprise standards).
F. Electrical schematic diagram of the product.
G. Product circuit diagram.
H. List of key components or raw materials.
I. Testing Report.
J. Certificates issued by NB, the EU Authorized Certification Authority (for models other than Mode A).
K. Certificate of registration of products in the EU (for some products such as Class I medical devices, ordinary IVD in vitro diagnostic medical devices).
L. CE Compliance Statement (DOC).
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