Along with the rise of the China’s due diligence, the requirement of providing CE certificate has become ubiquitous. But to the surprise of many companies importing from China, CE certificate has some limitations, and even if it was confirmed by the issuing agency, it does not necessary guarantee the quality of imported products. What should we remember to avoid problems?
First of all, the issuer of the Certificate of Verification of Compliance cannot be held responsible for non-conformity of the delivered product. While the onsite check was performed during the certificate application procedures, production line is not under constant surveillance. It opens space for fraud. For example, in many cases, the manufacturer is supplying different products using the same model name.
Another rule, which is often forgotten, is related with the Declaration of Conformity (DoC). As almost everybody knows, the document must include manufacturer’s details, essential characteristics the product complies, relevant standards and performance data and (if relevant) the identification number of the Notified Body. But we must also be aware of the another requirement: the manufacturer must issue and supply DoC for every single unit of product exported to Europe. It doesn’t matter whether you are purchasing, for example, 20 different models or 20 models of the same product: every model must have DoC.
In order to properly classify the medical device, we should use the information presented here. For medical devices defined as class IIa, the manufacturer should provide the proof of conformity assessment carried out by a Notified Body. The auditing procedures may include: examination and testing of each product or homogenous batch of products, audit of the production quality assurance system, audit of final inspection and testing, audit of the full quality assurance system.
Provided DoC must also include the name and address of the person (resident in Europe) able to constitute and to hold the Technical File (a comprehensive collection of information and documents detailing everything about your medical device).