Drugs, medical devices CE certification how to query?

European Union official website try to see: select the left side Body, enter the query, according to the CE bulletin number laboratory to check the certification body, you can see the contact information, and then by phone or e-mail, to confirm the certification of the product information.

If you want to check the product is imported from abroad, the original products of well-known companies, as long as you can ensure that the purchase channel is formal, the product is genuine. The product should certainly be done CE certification, because CE in the European Union is a mandatory certification.

CE certification to prepare the technical documents

1. Product instruction manual.

2. Safety design documents (including key structural drawings, that is, to reflect the creepage distance, clearance, insulation and thickness of the design drawings).

3. Product technical conditions (or enterprise standards), the establishment of technical information.

4. Electrical schematic diagrams, wiring diagrams, block diagrams

5. Key components or raw materials list (please use the European certification mark of the product).

6. A copy of the whole machine or component certification.

These documents are required by the certification body to protect the confidentiality of the customer, so the website is not available.