MDCG 2020-6 (欧盟)2017∕745号法规此前根据93∕42∕EEC指令或90∕385∕EEC指令获得CE标志的医疗器械所需临床证据
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MDCG 2020-6
Medical Device Coordination Group Document
Medical Device
MDCG 2020-6
2017/745 93/42/EEC 90/
385/EEC CE
2020 4
2017/745 103 MDCG
MDCG
2017/745 93/42/EEC 90/385/EEC
CE
Page 2 of 22
1. ................................................................................................................................................4
1.1. MDR 2 ........................................................ 4
1.2. MDR 2 ...................................................................................... 4
2. .......................................................................................................................................6
3. ................................................................................................................................................6
4. ...................................................................................................................................7
5. .........................................................................................................................................8
6. ............................................................................... 10
6.1. XIV A 1a ...................................................... 10
6.2. XIV A 1b .............................................................. 11
6.2.1. ................................................................................................ 12
6.2.2. .................................................................................................. 12
6.3. XIV A 1c ......................................................................... 12
6.4. XIV A 1d .................................................................. 13
6.5. XIV A 1e .......................................................................... 14
I - MDR MEDDEV 2.7/1 rev. 4
............................................................................................................................. 18
....................................................................................................... 19
-
MDRGSPR ....................................... 20
Page 3 of 22
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作者：一如既往
分类：法规规范
价格：120质量币
属性：22 页
大小：1.95MB
格式：PDF
时间：2026-03-17
