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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) Commission Delegated Regulation (EU) 2022/8037 specifies the rules of procedure that apply to the European Securities and Markets Authority (‘ESMA’) for the exercise of the power to impose fines, as referred to in Article …

(fra kommisjonsforordningen) (1) Issuers of bonds marketed as environmentally sustainable and of sustainability-linked bonds may choose to disclose the information referred to in Article 21 of Regulation 2023/2631 using the common templates. There is no …

(fra kommisjonsforordningen) (1) To give full effect to the right to be heard, as guaranteed in Article 63(5) of Regulation (EU) 2023/2631, a person that is subject to an investigation by ESMA because that person may have committed one of the …

(fra kommisjonsforordningen) (1) Fees that the European Securities Market Authority (ESMA) is to charge to external reviewers of European Green Bonds should fully recover all costs ESMA incurs for the registration, recognition and supervision of external …

(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) Requirements for the arrangements, procedures and systems that persons professionally arranging or executing transactions in crypto-assets are to have in place for the reporting of orders, transactions and other aspects …

(fra kommisjonsforordningen) (1) Regulation (EU) No 2024/2987 of the European Parliament and of the Council introduced into Regulation (EU) No 648/2012 changes to the functioning and management of CCP colleges. In particular, a new co-chair has been …

(fra kommisjonsforordningen) (1) To enable competent authorities to assess whether legal persons or other undertakings that intend to offer to the public or seek the admission to trading of asset-referenced tokens (‘applicant issuers’) meet the …

(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) Clear and harmonised reporting instructions for data to be transmitted to and disseminated by consolidated tape providers (‘CTPs’) is a key element for the orderly functioning of CTPs and effective and reliable data …

(fra kommisjonsforordningen) (1) Article 2(1), point (36a), of Regulation (EU) No 600/2014 defines data reporting services providers (DRSPs) as approved publication arrangements (APAs), approved reporting mechanisms (ARMs), and consolidated tape providers …

(fra kommisjonsforordningen) (1) To ensure that market data is provided on a reasonable commercial basis (ʿRCBʼ), with unbiased and fair contractual terms and in a uniform manner across the Union, it is necessary to specify the conditions that market …