Commission Delegated Regulation (EU) …/... amending Delegated Regulation (EU) 2022/805 as regards harmonisation of certain aspects of fees charged by the European Securities and Markets Authority to certain benchmark administrators
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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) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
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Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2016/1011 as regards the scope of the rules for benchmarks, the use in the Union of benchmarks provided by an administrator located in a third country, and certain reporting requirements
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C(2023)4849
Commission Delegated Regulation (EU) 2023/2222 of 14 July 2023 extending the transitional period laid down for third-country benchmarks in Article 51(5) of Regulation (EU) 2016/1011 of the European Parliament and the Council
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2023/2222 frá 14. júlí 2023 um framlengingu á umbreytingartímabilinu sem mælt er fyrir um fyrir viðmiðanir þriðja lands í 5. mgr. 51. gr. reglugerðar Evrópuþingsins og ráðsins (ESB) 2016/1011
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 Recommendation (EU) 2023/1425 of 27 June 2023 on facilitating finance for the transition to a sustainable economy
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C(2023)3851
Commission Delegated Regulation (EU) 2023/2486 of 27 June 2023 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to the sustainable use and protection of water and marine resources, to the transition to a circular economy, to pollution prevention and control, or to the protection and restoration of biodiversity and ecosystems and for determining whether that economic activity causes no significant harm to any of the other environmental objectives and amending Commission Delegated Regulation (EU) 2021/2178 as regards specific public disclosures for those economic activities
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C(2023)3850
Commission Delegated Regulation (EU) 2023/2485 of 27 June 2023 amending Delegated Regulation (EU) 2021/2139 establishing additional technical screening criteria for determining the conditions under which certain economic activities qualify as contributing substantially to climate change mitigation or climate change adaptation and for determining whether those activities cause no significant harm to any of the other environmental objectives
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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
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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Commission Implementing Regulation (EU) 2022/2454 of 14 December 2022 laying down implementing technical standards for the application of Directive 2002/87/EC of the European Parliament and of the Council with regard to supervisory reporting of risk concentrations and intra-group transactions
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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
C(2022)7545
Commission Delegated Regulation (EU) 2023/363 of 31 October 2022 amending and correcting the regulatory technical standards laid down in Delegated Regulation (EU) 2022/1288 as regards the content and presentation of information in relation to disclosures in pre-contractual documents and periodic reports for financial products investing in environmentally sustainable economic activities
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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
Commission Delegated Regulation (EU) 2022/1666 of 13 June 2022 correcting the Danish language version of Annex II to Delegated Regulation (EU) 2017/653 supplementing Regulation (EU) No 1286/2014 of the European Parliament and of the Council on key information documents for packaged retail and insurance-based investment products (PRIIPs) by laying down regulatory technical standards with regard to the presentation, content, review and revision of key information documents and the conditions for fulfilling the requirement to provide such documents
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2022/1666 frá 13. júní 2022 um leiðréttingu á dönsku tungumálaútgáfunni á II. viðauka við framselda reglugerð (ESB) 2017/653 um viðbætur við reglugerð Evrópuþingsins og ráðsins (ESB) nr. 1286/2014 um lykilupplýsingaskjöl fyrir pakkaðar og vátryggingatengdar fjárfestingarafurðir fyrir almenna fjárfesta (PRIIP) með því að mæla fyrir um tæknilega eftirlitsstaðla að því er varðar framsetningu, inntak, yfirferð og endurskoðun lykilupplýsingaskjala og skilyrðin fyrir því að uppfylla kröfur um að láta slík skjöl í té
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