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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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EU Medical Device Regulations
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
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FAQs
Sticky
Regulation (EU) 2017/745 of the European Parliament
Marc
Dec 13, 2018
2
Replies
13
Views
15K
Jun 15, 2021
KMohan27
K
Discussions
T
MDR - Rule 11 Software class I
TomQA
Wednesday at 6:49 AM
Replies
7
Views
130
Yesterday at 10:56 AM
mjamesl
M
J
UDI-DI does it always have to use the manufacturers GTIN?
JP12345
Wednesday at 4:58 AM
Replies
4
Views
90
Yesterday at 7:15 AM
Cybel
C
T
UDI-DI and level of packaging
TomQA
Feb 21, 2024
Replies
5
Views
277
Yesterday at 5:51 AM
Cybel
C
P
How to deal with documentation requirements MDD/MDR under 2023/607
Pzimmermann92
Yesterday at 4:11 AM
Replies
6
Views
69
Yesterday at 5:26 AM
Pzimmermann92
P
M
Are "recommendations" part of MDSW?
MarRz
Feb 12, 2024
Replies
5
Views
279
Tuesday at 11:19 AM
MarRz
M
M
IEC 62366 Hazard-related Use Scenario vs FDA Critical Task
mdreg
Sep 19, 2022
Replies
5
Views
1K
Tuesday at 8:46 AM
EmiliaBedelia
E
B
Notified Body changed the submission deadlines for NC, CAPA Plans
bimeri
Mar 21, 2024
Replies
7
Views
203
Sunday at 11:23 AM
Philip B
P
M
Does my "new" assay require a clinical study? or will a reference interval study suffice? in Japan Medical Device Regulations.
Mike W
Mar 21, 2024
Replies
0
Views
60
Mar 21, 2024
Mike W
M
AFAP principe in Supplier pFMEA
KiraKiwaKilowatt
Mar 20, 2024
Replies
4
Views
132
Mar 20, 2024
yodon
Y
P
All Post-marketing studies = PMCF?
partyhats
Jun 22, 2023
Replies
1
Views
303
Mar 20, 2024
VI Me
V
I
2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website
Ioko
May 27, 2019
2
3
4
Replies
39
Views
18K
Mar 19, 2024
Cloud808
C
C
Service Number - Labelling
CraigRegulatory
Mar 12, 2024
Replies
3
Views
171
Mar 18, 2024
CraigRegulatory
C
P
Question on Borderline
Philip B
Mar 4, 2024
Replies
1
Views
168
Mar 17, 2024
Vetty007
V
G
Be prepared for Stage 2 MDR onsite audit
Galac
Jan 30, 2024
Replies
4
Views
296
Mar 15, 2024
EmiliaBedelia
E
R
EUDAMED function
ruthwu
Mar 13, 2024
Replies
1
Views
149
Mar 14, 2024
emili
E
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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