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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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UDI and EAN
ines ha
Apr 2, 2024
Replies
3
Views
172
Apr 3, 2024
Cybel
C
J
UDI-DI does it always have to use the manufacturers GTIN?
JP12345
Mar 27, 2024
Replies
8
Views
374
Apr 3, 2024
Billy Milly
B
Understanding Latest MDR Notified Body Report
Ed Panek
Apr 1, 2024
Replies
1
Views
167
Apr 2, 2024
dgrainger
P
How to deal with documentation requirements MDD/MDR under 2023/607
Pzimmermann92
Mar 28, 2024
Replies
7
Views
364
Apr 1, 2024
EmiliaBedelia
E
T
UDI-DI and level of packaging
TomQA
Feb 21, 2024
Replies
5
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416
Mar 28, 2024
Cybel
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M
Are "recommendations" part of MDSW?
MarRz
Feb 12, 2024
Replies
5
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367
Mar 26, 2024
MarRz
M
M
IEC 62366 Hazard-related Use Scenario vs FDA Critical Task
mdreg
Sep 19, 2022
Replies
5
Views
1K
Mar 26, 2024
EmiliaBedelia
E
B
Notified Body changed the submission deadlines for NC, CAPA Plans
bimeri
Mar 21, 2024
Replies
7
Views
287
Mar 24, 2024
Philip B
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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
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105
Mar 21, 2024
Mike W
M
AFAP principe in Supplier pFMEA
KiraKiwaKilowatt
Mar 20, 2024
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4
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212
Mar 20, 2024
yodon
Y
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All Post-marketing studies = PMCF?
partyhats
Jun 22, 2023
Replies
1
Views
393
Mar 20, 2024
VI Me
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2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website
Ioko
May 27, 2019
2
3
4
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39
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18K
Mar 19, 2024
Cloud808
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C
Service Number - Labelling
CraigRegulatory
Mar 12, 2024
Replies
3
Views
243
Mar 18, 2024
CraigRegulatory
C
P
Question on Borderline
Philip B
Mar 4, 2024
Replies
1
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220
Mar 17, 2024
Vetty007
V
G
Be prepared for Stage 2 MDR onsite audit
Galac
Jan 30, 2024
Replies
4
Views
399
Mar 15, 2024
EmiliaBedelia
E
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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