Leit í EES-gagnagrunni
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
Proposal for a Directive of the European Parliament and of the Council establishing the European Disability Card and the European Parking Card for persons with disabilities
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 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
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
Administrative Commission for the Coordination of Social Security Systems Decision No H13 of 30 March 2022 concerning the composition and working methods of the Audit Board of the Administrative Commission for the Coordination of Social Security Systems
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
Decision No H12 of 19 October 2021 concerning the date to be taken into consideration for determining the rates of conversion referred to in Article 90 of Regulation (EC) No 987/2009 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2021/2078 frá 26. nóvember 2021 um reglur um beitingu reglugerðar Evrópuþingsins og ráðsins (ESB) 2017/745 að því er varðar Evrópska gagnabankann um lækningatæki
D075298/03
Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2021/2226 frá 14. desember 2021 um reglur um beitingu reglugerðar Evrópuþingsins og ráðsins (ESB) 2017/745 að því er varðar rafrænar notkunarleiðbeiningar fyrir lækningatæki
COM(2021) 627
Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
Reglugerð Evrópuþingsins og ráðsins (ESB) 2022/112 frá 25. janúar 2022 um breytingu á reglugerð (ESB) 2017/746 að því er varðar umbreytingarákvæði um tiltekin lækningatæki til sjúkdómsgreiningar í glasi og um að fresta beitingu skilyrða vegna tækja innanhúss
Administrative Commission for the Coordination of Social Security Systems Decision No S11 of 9 December 2020 concerning refund procedures for the implementation of Articles 35 and 41 of Regulation (EC) No 883/2004
Decision No H11 of 9 December 2020 regarding the postponement of deadlines mentioned in Articles 67 and 70 of Regulation (EC) No 987/2009 as well as in Decision No S9 due to the COVID-19 Pandemic
Ákvörðun nr. H11 frá 9. desember 2020 varðandi framlengingu fresta sem um getur í 67. og 70. gr. reglugerðar (EB) nr. 987/2009 og í ákvörðun nr. S9 vegna COVID-19 heimsfaraldursins
Administrative Commission for the Coordination of Social Security Systems Decision No H10 of 21 October 2020 concerning the methods of operation and the composition of the Technical Commission for Data Processing of the Administrative Commission for the Coordination of Social Security Systems
Administrative Commission for the Coordination of Social Security Systems Decision No H9 of 17 June 2020 regarding the postponement of deadlines mentioned in Articles 67 and 70 of Regulation (EC) No 987/2009 of the European Parliament and of the Council as well as in Decision No S9 due to the COVID-19 Pandemic
Framkvæmdaráð um samræmingu almannatryggingakerfa Ákvörðun nr. H9 frá 17. júní 2020 varðandi framlengingu fresta sem um getur í 67. og 70. gr. reglugerðar Evrópuþingsins og ráðsins (EB) nr. 987/2009 og í ákvörðun nr. S9 vegna COVID-19 heimsfaraldursins
Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies
Framkvæmdarreglugerð framkvæmdastjórnarinnar (ESB) 2020/666 frá 18. maí 2020 um breytingu á framkvæmdarreglugerð (ESB) nr. 920/2013 að því er varðar endurnýjun tilnefninga og eftirlit með tilkynntum aðilum og vöktun á þeim