Commission Delegated Decision (EU) …/… on the renewal of the determination that the solvency regime in force in the United States applicable to undertaking with their head office in that third country is provisionally equivalent to that laid down in Title I, Chapter VI of Directive 2009/138/EC of the European Parliament and of the Council
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
Commission Implementing Regulation (EU) 2024/456 of 7 February 2024 laying down technical information for the calculation of technical provisions and basic own funds for reporting with reference dates from 31 December 2023 until 30 March 2024 in accordance with Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
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
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
C(2023)8171
Commission Delegated Regulation (EU) 2024/896 of 5 December 2023 amending Directive (EU) 2016/97 of the European Parliament and of the Council as regards the regulatory technical standards adapting the base amounts in euro for professional indemnity insurance and for financial capacity of insurance, reinsurance and ancillary insurance intermediaries
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
Commission Implementing Regulation (EU) 2023/2574 of 20 November 2023 laying down technical information for the calculation of technical provisions and basic own funds for reporting with reference dates from 30 September 2023 until 30 December 2023 in accordance with Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
Commission Implementing Regulation (EU) 2023/1672 of 30 August 2023 laying down technical information for the calculation of technical provisions and basic own funds for reporting with reference dates from 30 June 2023 until 29 September 2023 in accordance with Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
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
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
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 Regulation (EU) 2023/895 of 4 April 2023 laying down implementing technical standards for the application of Directive 2009/138/EC of the European Parliament and the Council with regard to the procedures, formats and templates for the disclosure by insurance and reinsurance undertakings of their report on their solvency and financial condition and repealing Implementing Regulation (EU) 2015/2452
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
Commission Implementing Regulation (EU) 2023/894 of 4 April 2023 laying down implementing technical standards for the application of Directive 2009/138/EC of the European Parliament and the Council with regard to the templates for the submission by insurance and reinsurance undertakings to their supervisory authorities of information necessary for their supervision and repealing Implementing Regulation (EU) 2015/2450
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
Commission Implementing Regulation (EU) 2023/967 of 16 May 2023 laying down technical information for the calculation of technical provisions and basic own funds for reporting with reference dates from 31 March 2023 until 29 June 2023 in accordance with Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
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
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
Commission Implementing Regulation (EU) 2023/266 of 9 February 2023 laying down technical information for the calculation of technical provisions and basic own funds for reporting with reference dates from 31 December 2022 until 30 March 2023 in accordance with Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
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
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
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
Commission Implementing Regulation (EU) 2022/2282 of 21 November 2022 laying down technical information for the calculation of technical provisions and basic own funds for reporting with reference dates from 30 September 2022 until 30 December 2022 in accordance with Directive 2009/138/EC of the European Parliament and of the Council on the taking-up and pursuit of the business of Insurance and Reinsurance
Verði gerð tekin upp í EES-samninginn birtist hún hér á íslensku eftir birtingu í EES-viðbæti
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