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CELEX:52022DC0182: REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
by European Commission, Directorate-General for Health and Food Safety
PI_COM:Ares(2022)951115: COMMISSION IMPLEMENTING REGULATION (EU) …/… 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
by European Commission, Directorate-General for Health and Food Safety
PI_COM:Ares(2021)7122754: COMMISSION IMPLEMENTING REGULATION (EU) …/… 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
by Directorate-General for Health and Food Safety, European Commission
PI_COM:Ares(2021)7122928: COMMISSION IMPLEMENTING REGULATION (EU) …/… 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
by Directorate-General for Health and Food Safety, European Commission
PI_COM:Ares(2017)4704363: COMMISSION IMPLEMENTING REGULATION (EU) …/… on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council
by European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
CELEX:32023R0503: 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 (Text with EEA relevance)
March 7, 2023 by European Commission, Directorate-General for Health and Food Safety
CELEX:32022R1107: 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 (Text with EEA relevance)
July 4, 2022 by European Commission, Directorate-General for Health and Food Safety
CELEX:32022R0945: 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 (Text with EEA relevance)
June 19, 2022 by Directorate-General for Health and Food Safety, European Commission
CELEX:32022R0944: 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 (Text with EEA relevance)
June 19, 2022 by European Commission, Directorate-General for Health and Food Safety
CELEX:52021XC0111(01): Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment (Text with EEA relevance) 2021/C 8/01
January 10, 2021 by Directorate-General for Health and Food Safety, European Commission
CELEX:32019D0939: Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (Text with EEA relevance.)
June 6, 2019 by Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
CELEX:32017R2185: Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. )
November 23, 2017 by European Commission, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

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