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  • A.8.2.2 Labeling of Information

    Since you stated in the SoA that control A.8.2.2 Labelling of information is not applicable, then it is sufficient for you to include only N/A in the Labeling column (there is no need to exclude the column).

    Regarding controls A.8.2.1 Classification of information and A.8.2.2, you can implement only A.8.2.1 without implementing A.8.2.2 (i.e., you can define classification levels without the need to label media that contains it, although this is not common).

    For further information, see:

  • Adverse Event Reporting

    Yes, you can follow the same procedure. According to Article 16 from the MDR, if the CE mark of the manufacturer stays on the medical device, you do not consider a manufacturer, but rather the distributor.

    1 a) makes available on the market a device under its name, registered trade name, or registered trademark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation.

    For more information, see:

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