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Eu Product Registration

Eu law requires non-EU medical device manufacturers to include the name and address of the manufacturer and the manufacturer's EU representative when applying the CE mark, printing labels and instructions. All IVDD of in vitro diagnostic medical devices (including reagents) and ALL MDD of Category I medical devices, when the CE mark is affixed, the eu representative must be entrusted to register the manufacturer and product information in the EU and enter the EU database. Before exporting, it is necessary to complete the registration in the EU to avoid problems when entering the EU customs.

Registration of general medical devices

For general medical device MDD: All Class I (including sterilized and metrological) medical device manufacturers or their authorized representatives in the EU must complete the registration of manufacturer and product information and obtain the registration number from the competent authorities in the country where they or their EU representatives are located at the time of the first CE marking. Manufacturers of custom-made medical devices, systems or packaging, and sterilization companies must register with the competent authorities and obtain registration numbers no later than when they first declare that they meet the requirements of the Medical Device Directive. For IVDD: all IVDDs manufacturers or their authorized representatives in the EU must complete registration and obtain the registration number at the time of the first CE mark.

Eu Product Registration

Registration of general medical devices

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Database

400-0569-812

Database

400-0569-812