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每頁顯示20 條，共找到 361 條結果 <1/19>
標準編號 標準名稱 發布部門 發布日期 狀態
EU MDCG 2021-5 Rev. 1:2024 Guidance on standardisation for medical devices European U.. 2024-09-03 現行
EU MDCG 2024-3:2024 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices European U.. 2024-05-22 現行
2014/68/EU : 2014 COR 1 2015 DIRECTIVE 2014/68/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 15 MAY 2014 ON THE HARMONISATION OF THE LAWS OF THE MEMBER STATES RELATING TO THE MAKING AVAILABLE ON THE MARKET OF PRESSURE EQUIPMENT TEXT WITH EEA RELEVANCE European U.. 2023-07-17 現行
EU MDCG 2021-27:2021 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 European U.. 2022-04-11 現行
REGULATION (EU) 2021/2078:2021 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) European U.. 2022-04-11 現行
EU MDCG 2021-28:2021 Substantial modification of clinical investigation under Medical Device Regulation European U.. 2022-04-11 現行
REGULATION (EU) 2021/2226:2021 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 European U.. 2022-04-11 現行
EU MDCG 2022-2:2022 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) European U.. 2022-04-11 現行
EU MDCG 2022-1:2022 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices European U.. 2022-04-11 現行
REGULATION(EU)2022/112:2022 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 European U.. 2022-04-11 現行
EU MDCG 2022-3:2022 Verification of manufactured class D IVDs by notified bodies European U.. 2022-04-11 現行
EU MDCG 2022-4:2022 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD European U.. 2022-04-11 現行
EU MDCG 2021-24 : 2021 Guidance on classification of medical devices European U.. 2022-04-11 現行
EU MDCG 2021-26:2021 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 European U.. 2022-04-11 現行
EU MDCG 2021-25:2021 Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC European U.. 2022-04-11 現行
EU MDCG 2021-21:2021 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices European U.. 2022-04-11 現行
EU MDCG 2021-19 : 2021 Guidance note integration of the UDI within an organisation’s quality management system European U.. 2022-04-11 現行
EU MDCG 2021-14:2021 Explanatory note on IVDR codes European U.. 2022-04-11 現行
EU MDCG 2021-20:2021 Instructions for generating CIV-ID for MDR Clinical Investigations European U.. 2022-04-11 現行
EU MDCG 2021-13 REV 1:2021 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR European U.. 2022-04-11 現行
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