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DIMDI medical devices
Necessity
According to the EU Regulation 765/2008EC Artikel 30 on certification and market supervision related to product marketing, medical device products are one of the products that must bear CE mark, as are active implantable medical devices and IVD devices, and with CE mark means that the product complies with the EU product quality standards; According to the requirements of Annex 2, the CE mark shall meet the following size ratio requirements and be at least 5mm high; According to DIRECTIVE 9342EEC Artikel 9, medical devices are divided into I (ordinary I, I with measurement function and I sterilization type), IIa, IIb and III. Ordinary I requires the manufacturer to issue a Declaration of Conformity (DOC), while other products require the notified body recognized by the EU to test and issue a test certificate. After obtaining the certificate, The four identification code of the notified body must be written in the lower right corner of CE.
According to the EU Medical Device Products DIRECTIVE 9342EEC Artikel 14 or the German Medical Device Products Law MPG § 25 Abs. 1, the IVD Device Directive RICHTLINIE 9879EG Artikel 10, and the active implantable medical devices refer to RICHTLINIE 90385EWG Artikel 10, all the above products need manufacturers or local distributors or their EU representatives (if manufacturers are from outside the EU) register with the competent authority of the corresponding EU member state (UK MHRA), in Germany is to file on DIMDI, and obtain a file number in the form of DE/XXXX/XXXXXX/XX.
Mark
The product must pass corresponding test before it is qualified to bear the mark, so do not use the certification mark of any country or any ahthority at will.
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