Do medical device manufacturers who do not use their own trademarks need to apply for CE certification mark?
Do medical device manufacturers who do not use their own trademarks need to apply for CE certification mark?
For many domestic medical device exporters, it is necessary to understand the definition of the manufacturer of the MDD in the MDD, which is quite different from the traditional manufacturer concept. Definition in MDD is:A manufacturer is the person responsible for the design, production, packaging, and labeling of a medical device in its own name before it is placed on the market, regardless of whether the worker is carried out by himself or a third party on his behalf. In this directive, the responsibility that the manufacturer needs to meet also applies to those people assembly, packaging, processing, refurbishment and/or labeling and/or determining the intended use of one or more off-the-shelf products and put them on the market in their own name.
It is stipulated in the MDD that the manufacturer is responsible for the CE certification mark and shall assume all responsibility as stipulated in the directive. Therefore, if the products exported by domestic manufacturers are exported in the name of foreign importers, then in principle, it is not necessary to apply for the CE certification mark. However, for medical devices of Class II a (including I*) and above, if European companies import and import their own trademarks, the notified bodies of these European companies generally need the certificates of the actual Chinese manufacturers. If these Chinese companies have ISO 9000 and EN 46000 certificates, they will meet the requirements for subcontracting, but if these domestic manufacturers intend to sell medical devices in Europe in their own name, they must also obtain CE certification.