Commission Implementing Regulation (EU) …/... of XXX establishing a common form for rail passengers’ reimbursement and compensation requests for delays, missed connections and cancellations of rail services in accordance with Regulation (EU) 2021/782 of the European Parliament and of the Council
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Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices
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Commission Implementing Regulation (EU) 2024/327 of 19 January 2024 repealing Implementing Regulation (EU) 2015/429 setting out the modalities to be followed for the application of the charging for the cost of noise effects
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Commission Implementing Regulation (EU) 2024/191 of 8 January 2024 correcting certain language versions of Regulation (EU) No 1303/2014 concerning the technical specification for interoperability relating to safety in railway tunnels of the rail system of the European Union
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Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
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Commission Implementing Decision (EU) 2023/1696 of 10 August 2023 amending Implementing Decision 2011/665/EU as regards the specification for the European register of authorised types of vehicles referred to in Article 48 of Directive (EU) 2016/797 of the European Parliament and of the Council
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Commission Implementing Regulation (EU) 2023/1695 of 10 August 2023 on the technical specification for interoperability relating to the control-command and signalling subsystems of the rail system in the European Union and repealing Regulation (EU) 2016/919
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Commission Implementing Regulation (EU) 2023/1694 of 10 August 2023 amending Regulations (EU) No 321/2013, (EU) No 1299/2014, (EU) No 1300/2014, (EU) No 1301/2014, (EU) No 1302/2014, (EU) No 1304/2014 and Implementing Regulation (EU) 2019/777
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Commission Implementing Regulation (EU) 2023/1693 of 10 August 2023 amending Implementing Regulation (EU) 2019/773 on the technical specification for interoperability relating to the operation and traffic management subsystem of the rail system within the European Union
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Proposal for a Regulation of the European Parliament and of the Council on the use of railway infrastructure capacity in the single European railway area, amending Directive 2012/34/EU and repealing Regulation (EU) No 913/2010
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C(2023)4568
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
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Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2023/1194 frá 20. júní 2023 um breytingu á framkvæmdarreglugerð (ESB) 2022/2346 að því er varðar umbreytingarákvæði vegna tiltekinna vara án ætlaðs læknisfræðilegs tilgangs sem eru tilgreindar í XVI. viðauka við reglugerð Evrópuþingsins og ráðsins (ESB) 2017/745
Commission Implementing Decision .../... on the authorisation to place on the Union market in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council certain medical devices manufactured by Maquet Cardiopulmonary GmbH
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COM(2023) 10
Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
Reglugerð Evrópuþingsins og ráðsins (ESB) 2023/607 frá 15. mars 2023 um breytingu á reglugerðum (ESB) 2017/745 og (ESB) 2017/746 að því er varðar umbreytingarákvæði um tiltekin lækningatæki og lækningatæki til sjúkdómsgreiningar í glasi
C(2022)8649
Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 amending Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2023/503 frá 1. desember 2022 um breytingu á reglugerð Evrópuþingsins og ráðsins (ESB) 2017/746 að því er varðar tíðni heildarendurmata á tilkynntum aðilum
Commission Implementing Regulation (EU) 2023/62 of 5 January 2023 correcting the Polish language version of Regulation (EU) No 1300/2014 on the technical specifications for interoperability relating to accessibility of the Union’s rail system for persons with disabilities and persons with reduced mobility
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COM(2022) 721
Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95
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C(2022)8640
Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2023/502 frá 1. desember 2022 um breytingu á reglugerð Evrópuþingsins og ráðsins (ESB) 2017/745 að því er varðar tíðni heildarendurmata á tilkynntum aðilum
D080753/07
Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2022/2347 frá 1. desember 2022 um reglur um beitingu reglugerðar Evrópuþingsins og ráðsins (ESB) 2017/745 að því er varðar endurflokkun flokka tiltekinna virkra vara án ætlaðs læknisfræðilegs tilgangs
D080753/04
Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2022/2346 frá 1. desember 2022 um sameiginlegar forskriftir fyrir flokka vara án ætlaðs læknisfræðilegs tilgangs sem eru tilgreindir í XVI. viðauka við reglugerð Evrópuþingsins og ráðsins (ESB) 2017/745 um lækningatæki