For many domestic medical device export manufacturers, it is necessary to understand the definition of MDD manufacturers, which is different from the traditional concept of manufacturers. In MDD, a manufacturer is a person responsible for the design, production, packaging, and labeling of a medical device before it is placed on the market in his own name, regardless of whether these workers are carried out in his own name or by a third party. The responsibilities to be met by manufacturers in this Directive also apply to those who assemble, package, process, refurbishment and/or label and/or determine the intended use of one or more off-the-shelf products and place them on the market under their own name.

 

The MDD stipulates that the manufacturer is responsible for the CE certification mark and shall assume all the responsibilities specified in the Directive. Therefore, if the products exported by domestic manufacturers are exported in the name of foreign importers, then in principle there is no need to apply for CE certification mark. However, for medical devices above Class II a (including I*), if European companies import and mark their own trademarks from China, generally the notified bodies of these European companies will need the proof of the actual manufacturer in China. If these Chinese companies have ISO 9000 and EN 46000 certificates, then they meet the requirements as subcontractors, but if these domestic manufacturers intend to sell medical devices in their own name in Europe in the future, they must also obtain CE certification.