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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) In accordance with Regulation (EU) 2019/6, holders of a manufacturing authorisation (‘manufacturers’) are required to comply with good manufacturing practice. Compliance with good manufacturing practice is required for the …

(fra kommisjonsforordningen) (1) Pharmacologically active substances are classified on the basis of opinions on maximum residue limits (MRLs) issued by the European Medicines Agency (EMA).  (2) An application for an opinion to establish the MRL is …

(fra kommisjonsforordningen) (1) In accordance with Regulation (EU) 2019/6, veterinary medicinal products manufactured in the Union, including veterinary medicinal products intended for export as well as veterinary medicinal products imported into the …

(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) Regulation (EC) No 273/2004 lays down measures for monitoring trade in drug precursors within the Union, while Regulation (EC) No 111/2005 governs trade in drug precursors between the Union and third countries. Annex I to …

(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 …

(fra kommisjonsforordningen) (1) Commission Implementing Regulation (EU) 2021/2226 limits its application to certain medical devices and their accessories.  (2) The results of a survey on replacing paper-based instructions for use by electronic …