Sökning: "IVDMD"

Hittade 1 uppsats innehållade ordet IVDMD.

  1. 1. Approved medicinal products with potential companion diagnostic tests : An Inventory of the Swedish/European drug market

    Master-uppsats, Uppsala universitet/Institutionen för farmaceutisk biovetenskap

    Författare :Katrin Andersson; [2023]
    Nyckelord :CDx; Companion Diagnostic; IVDMD; In-vitro diagnostic medical devices; Regulation EU 2017 746;

    Sammanfattning : The newly introduced regulation (EU) 2017/746 aims to make In Vitro Diagnostic Medical Devices (IVDMD), which include companion diagnostic tests (CDx), a widespread method of authorising medicinal products in the European market. However, European SmPCs (Summary of Product Characteristics) currently do not explicitly refer to the term or classify tests associated with medicinal products as CDx. LÄS MER