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BAKGRUNN (fra kommisjonsbeslutningen) (1) Maquet Cardiopulmonary GmbH (MCP), is manufacturing heart-lung support (HLS), permanent life support (PLS) and heparin-induced thrombocytopenia (HIT) sets. These sets are devices intended for extracorporeal …

(fra kommisjonsforordningen) (1) Regulation (EU) 2016/792 lays down a common framework for the development, production and dissemination of the following harmonised indices: the harmonised index of consumer prices (HICP), the harmonised index of consumer …

(fra kommisjonsforordningen) (1) Commission Delegated Regulation (EU) 2023/2197 amended Regulation (EU) 2017/745 as regards the assignment of Unique Device Identifiers (UDI) for contact lenses as highly individualised devices, by introducing the ‘Master …

(fra kommisjonsforordningen) (1) Regulation (EU) 2017/745 provides for a Unique Device Identification (UDI) system for the identification and traceability of devices. Before placing a device, other than a custom-made device, on the market, the …