欧盟 - 出版社标准列表

每页显示20 条，共找到 361 条结果 <1/19>

标准编号	标准名称	发布部门	发布日期	状态
EU MDCG 2021-5 Rev. 1:2024	Guidance on standardisation for medical devices	European U..	2024-09-03	现行
EU MDCG 2024-3:2024	Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices	European U..	2024-05-22	现行
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	现行
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	现行
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	现行
EU MDCG 2021-28:2021	Substantial modification of clinical investigation under Medical Device Regulation	European U..	2022-04-11	现行
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	现行
EU MDCG 2022-2:2022	Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)	European U..	2022-04-11	现行
EU MDCG 2022-1:2022	Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices	European U..	2022-04-11	现行
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	现行
EU MDCG 2022-3:2022	Verification of manufactured class D IVDs by notified bodies	European U..	2022-04-11	现行
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	现行
EU MDCG 2021-24 : 2021	Guidance on classification of medical devices	European U..	2022-04-11	现行
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	现行
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	现行
EU MDCG 2021-21:2021	Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices	European U..	2022-04-11	现行
EU MDCG 2021-19 : 2021	Guidance note integration of the UDI within an organisation’s quality management system	European U..	2022-04-11	现行
EU MDCG 2021-14:2021	Explanatory note on IVDR codes	European U..	2022-04-11	现行
EU MDCG 2021-20:2021	Instructions for generating CIV-ID for MDR Clinical Investigations	European U..	2022-04-11	现行
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	现行

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