全套 2020 新版MDR法规指南文件： MDCG 2020-1 ~ 18 (2021/01/23)

2iso · 发表于 2021-1-23 18:52:11

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2020 新版MDR法规指南文件： MDCG 2020-1 ~ 18 (2021/01/23)

01 MDCG 2020-1-Guidance on Clinical Evaluation (MDR) Performance Evaluation (IVDR) of Medical Device Software
https://www.ouryao.com/thread-632734-1-1.html

02 MDCG 2020-2-Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
https://www.ouryao.com/thread-632735-1-1.html

03 md_mdcg_2020_3-guidance_significant_changes_annexes_en
https://www.ouryao.com/forum.php ... &highlight=MDCG

04 md_mdcg_2020_4_nb_audits_covid-19_en
https://www.ouryao.com/thread-632740-1-1.html

05 MDCG 2020-5 md_mdcg_2020_5_guidance_clinical_evaluation_equivalence
https://www.ouryao.com/forum.php ... &highlight=MDCG

06 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices
https://www.ouryao.com/thread-632736-1-1.html

07 MDCG 2020-7 Guidance on PMCF Plan Template
https://www.ouryao.com/thread-632737-1-1.html

08 MDCG 2020-8 Guidance on PMCF Evaluation Report Template
https://www.ouryao.com/thread-632738-1-1.html

09 MDCG 2020-9 Regulatory Requirements for Ventilators and Reated Accessories
https://www.ouryao.com/thread-632739-1-1.html

10-1 md_mdcg_2020_10_1_guidance_safety_reporting_en
https://www.ouryao.com/thread-632741-1-1.html

10-2 md_mdcg_2020_10-2_guidance_safety_report_form_en
https://www.ouryao.com/thread-632742-1-1.html

11 md_mdcg_2020_11_nb_guidance_renewal_designation_en
https://www.ouryao.com/thread-632743-1-1.html

12 md_mdcg_2020_12_nb_guidance_transitional_provisions_en
https://www.ouryao.com/thread-632744-1-1.html

13 MDCG 2020-13 md_2020-13-cea-report-template
https://www.ouryao.com/forum.php ... &highlight=MDCG

14 md_mdcg_2020_14-NB-guidance-mdsap_en
https://www.ouryao.com/thread-632745-1-1.html

15 md_mdcg_2020_15-position-paper-actor-registration-module-EUDAMED_en
https://www.ouryao.com/thread-632755-1-1.html

16 md_mdcg_2020_16-guidance_classification_ivd-md_en
https://www.ouryao.com/thread-632756-1-1.html

17 md_mdcg_2020_17-guidance-mdcg-qa_en
https://www.ouryao.com/thread-632757-1-1.html

18 md_mdcg_2020_18_MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers-en
https://www.ouryao.com/thread-632758-1-1.html

补充内容 (2021-1-27 08:33):
觉得好，请点击专业度认可，谢谢！

补充内容 (2021-1-30 11:31):
2021/01/30

MDCG 2020-10/1 Appendix:Clinical investigation summary safety report form 附录：临床研究摘要安全报告表 (2020/05)
https://www.ouryao.com/thread-633241-1-1.html
MDCG 2020-10/2 Guidanceon ...

补充内容 (2021-1-30 11:32):
MDCG 2020-10/2 Guidanceon safety reporting in clinical investigations (Excel) 临床研究安全报告指南 (2020/05)
https://www.ouryao.com/thread-633239-1-1.html

补充内容 (2021-2-27 19:08):
MDCG 2021-1 Guidance administrative practices_en,31 pages ,2021/02
https://www.ouryao.com/thread-634876-1-1.html

2iso · 发表于 2021-1-24 09:19:24

觉得好，请点击专业度认可，谢谢！

Cory0971 · 发表于 2021-1-24 11:08:15

这也太专业了。哈哈

2iso · 发表于 2021-1-24 12:05:58

谢谢,觉得专业，请点击专业度认可，谢谢！

syhorchid · 发表于 2021-1-24 19:41:01

谢谢分享

永恒的时差 · 发表于 2021-1-25 09:09:43

感谢分享！！！

蒋小秋 · 发表于 2021-1-25 09:22:57

这也太专业了。哈哈

小知知 · 发表于 2021-1-25 09:43:12

点了点了

繁星星 · 发表于 2021-1-25 09:46:10

感谢楼主的分享，已点专业认可！

raimi1225 · 发表于 2021-1-25 10:57:23

谢谢分享，这也太专业了，点了点了

jacky110771 · 发表于 2021-1-25 11:20:55

非常感谢，辛苦了，太专业了

jbowney · 发表于 2021-1-25 11:30:50

专业齐整统一，厉害！

洁洁1 · 发表于 2021-1-25 13:34:20

Hito · 发表于 2021-1-25 14:03:18

谢谢楼主分享

lxyrdw521 · 发表于 2021-1-25 14:14:35

这也太专业了

一路高歌 · 发表于 2021-1-25 14:27:40

还不如将MDCG链接直接发出来

regis-success · 发表于 2021-1-25 17:35:54

谢谢分享

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范范艾米 · 发表于 2021-1-26 15:28:55

谢谢分享。下载学习一下。小红心已点亮。

c8xpe · 发表于 2021-1-27 08:06:26

十分的感谢，已经小红心

孙琳1 · 发表于 2021-1-27 08:09:23

谢谢分享。下载学习一下。

全套 2020 新版MDR法规 指南文件： MDCG 2020-1 ~ 18 (2021/01/23)

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全套 2020 新版MDR法规指南文件： MDCG 2020-1 ~ 18 (2021/01/23)