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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
C
Service Number - Labelling
CraigRegulatory
Mar 12, 2024
Replies
3
Views
143
Yesterday at 3:49 AM
CraigRegulatory
C
P
Question on Borderline
Philip B
Mar 4, 2024
Replies
1
Views
145
Sunday at 7:03 AM
Vetty007
V
G
Be prepared for Stage 2 MDR onsite audit
Galac
Jan 30, 2024
Replies
4
Views
274
Friday at 4:19 PM
EmiliaBedelia
E
R
EUDAMED function
ruthwu
Wednesday at 5:08 PM
Replies
1
Views
129
Thursday at 1:30 AM
emili
E
B
2021/2226 on Electronic Instructions for Use (IFU) for medical devices
bimeri
Mar 5, 2024
Replies
6
Views
236
Mar 8, 2024
EmiliaBedelia
E
I
MDD Certificate Extension with respect to 2023/607
imcooleh
Jan 16, 2024
Replies
9
Views
366
Mar 7, 2024
imcooleh
I
T
UDI-DI and level of packaging
TomQA
Feb 21, 2024
Replies
4
Views
234
Mar 4, 2024
Cybel
C
M
Manufacturer contact data on label?
MarRz
Feb 29, 2024
Replies
0
Views
146
Feb 29, 2024
MarRz
M
K
Special conditions for Class III custom made implantable in contact with the CNS
kreid
Feb 29, 2024
Replies
2
Views
82
Feb 29, 2024
kreid
K
S
POST-MARKET PERFORMANCE FOLLOW-UP
Sieun Baek
Feb 28, 2024
Replies
0
Views
118
Feb 28, 2024
Sieun Baek
S
Documented procedure - Eudamed Device Registration
JoCam
Feb 27, 2024
Replies
4
Views
152
Feb 27, 2024
JoCam
I
Strategy for Free Sale Certificate issuance?
IS1027
Feb 26, 2024
Replies
3
Views
131
Feb 27, 2024
Cybel
C
P
Systematic literature search (periodic?alternative route?)
Pzimmermann92
Feb 26, 2024
Replies
4
Views
147
Feb 27, 2024
Pzimmermann92
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Real world data registries
poppy.b
Feb 21, 2024
Replies
5
Views
224
Feb 23, 2024
yodon
Y
M
CE mark on the package (procedure / system pack?)
MarRz
Feb 19, 2024
Replies
4
Views
233
Feb 20, 2024
Ed Panek
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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