Leit í EES-gagnagrunni
Commission Implementing Regulation (EU) …/... of XXX laying down rules for the application of Regulation (EU) 2023/988 of the European Parliament and of the Council as regards the implementation of the interoperable interface of the Safety Gate Portal for providers of online marketplaces
Commission Implementing Regulation (EU) 2024/635 of 2 February 2024 amending Implementing Regulation (EU) 2015/2447 as regards the means of proof of the customs status of Union goods and certain provisions relating to Union transit procedures
Commission Delegated Regulation (EU) 2024/249 of 30 November 2023 amending Delegated Regulation (EU) 2015/2446 as regards common data requirements for the purposes of exchange and storage of certain information under the customs legislation
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
Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
D082031/05
Commission Implementing Regulation (EU) 2023/2712 of 5 December 2023 laying down rules for the application of Regulation (EU) 2019/1020 of the European Parliament and of the Council as regards the details of the information to be transmitted from national customs systems to the information and communication system for market surveillance concerning products placed under the customs procedure release for free circulation
C(2023)6149
Commission Delegated Directive (EU) 2024/242 of 27 September 2023 amending Directive 2009/43/EC of the European Parliament and of the Council as regards the updating of the list of defence-related products in line with the updated Common Military List of the European Union of 20 February 2023
Commission Delegated Directive (EU) 2023/277 of 5 October 2022 amending Directive 2009/43/EC of the European Parliament and of the Council as regards the updating of the list of defence-related products in line with the updated Common Military List of the European Union of 21 February 2022
Framseld tilskipun framkvæmdastjórnarinnar (ESB) 2023/277 frá 5. október 2022 um breytingu á tilskipun Evrópuþingsins og ráðsins 2009/43/EB að því er varðar uppfærslu á skránni yfir varnartengdar vörur í samræmi við uppfærðan sameiginlegan hergagnalista Evrópusambandsins frá 21. febrúar 2022
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
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2023/2197 frá 10. júlí 2023 um breytingu á reglugerð Evrópuþingsins og ráðsins (ESB) 2017/745 að því er varðar úthlutun einkvæmra tækjaauðkenninga fyrir snertilinsur
Commission Decision (EU) 2023/1338 of 28 June 2023 on the safety requirements to be met by European standards for certain children’s products and related products pursuant to Directive 2001/95/EC of the European Parliament and of the Council
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 (EU) 2023/975 of 15 May 2023 amending Commission Implementing Decision (EU) 2019/417 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC of the European Parliament and of the Council on general product safety and its notification system
Commission Implementing Decision (EU) 2023/733 of 3 April 2023 designating Union testing facilities for radio equipment and toys in accordance with Regulation (EU) 2019/1020 of the European Parliament and of the Council
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
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
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
Proposal for a Regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020
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
Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2022/1107 frá 4. júlí 2022 um sameiginlegar forskriftir fyrir tiltekin lækningatæki til sjúkdómsgreiningar í glasi í flokki D í samræmi við reglugerð Evrópuþingsins og ráðsins (ESB) 2017/746
Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2022/945 frá 17. júní 2022 um reglur um beitingu reglugerðar Evrópuþingsins og ráðsins (ESB) 2017/746 að því er varðar gjöld sem tilvísunarrannsóknarstofu Evrópusambandsins á sviði lækningatækja til sjúkdómsgreiningar í glasi er heimilt að leggja á
Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2022/944 frá 17. júní 2022 um reglur um beitingu reglugerðar Evrópuþingsins og ráðsins (ESB) 2017/746 að því er varðar verkefni og viðmiðanir fyrir tilvísunarrannsóknarstofur Evrópusambandsins á sviði lækningatækja til sjúkdómsgreiningar í glasi
D075791/04
Commission Implementing Regulation (EU) 2022/1267 of 20 July 2022 specifying the procedures for the designation of Union testing facilities for the purposes of market surveillance and verification of product compliance in accordance with Regulation (EU) 2019/1020 of the European Parliament and of the Council
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2022/1267 frá 20. júlí 2022 um að tilgreina verklagsreglur við tilnefningu prófunarstöðva Sambandsins vegna markaðseftirlits og sannprófunar á samræmi vöru við kröfur í samræmi við reglugerð Evrópuþingsins og ráðsins (ESB) 2019/1020