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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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J
Sticky
EU MDR getting closer - Special offer for Elsmar members 10/2020
JakobAAA
Oct 11, 2020
2
Replies
14
Views
1,571
Dec 10, 2020
JakobAAA
Sticky
Regulation (EU) 2017/745 of the European Parliament
Marc
Dec 13, 2018
2
Replies
12
Views
6,490
Dec 12, 2019
Watchcat
Discussions
M
MDR, RED and LVD - Should our device comply with them?
MateuszN
May 20, 2020
Replies
3
Views
418
7 minutes ago
Dana Kelly
R
MDR & depth of review by NB's
ralf90
Friday at 11:16 AM
Replies
7
Views
222
Today at 3:39 AM
ralf90
S
Medical device CER (clinical evaluation report) according to MDR
sebastien
Feb 12, 2019
2
Replies
19
Views
3,736
Today at 3:30 AM
CanChua
D
Surgical Instrument Tray Classification
drwallice
Oct 29, 2020
Replies
7
Views
487
Yesterday at 3:14 PM
Asia78
E
Medical Device - CE marking - Local market notifications
EliJones
Tuesday at 9:45 AM
Replies
0
Views
63
Tuesday at 9:45 AM
EliJones
J
Medical Device Vigilance decision tree FORM - Please share yours
Jnks_Meddev
Jan 29, 2019
2
Replies
15
Views
3,348
Tuesday at 3:35 AM
Developer_Germany
U
Power supply - Change From 160 to 300 Watts - Significant change?
Udirn1
Monday at 11:48 AM
Replies
0
Views
84
Monday at 11:48 AM
Udirn1
S
EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean?
ShRam
Feb 1, 2020
2
Replies
13
Views
2,401
Monday at 8:10 AM
theresareeb
Checklist for MDD to MDR gap analysis
shimonv
Feb 20, 2019
2
3
Replies
21
Views
18,102
Monday at 4:00 AM
Mikilk
D
Deciding whether or not pre-market clinical investigation is required for low risk device
DamienL
Nov 27, 2020
Replies
5
Views
324
Saturday at 4:37 AM
DamienL
A
IVD in MDR procedure pack
Anonymo
Dec 29, 2020
Replies
2
Views
143
Friday at 10:24 AM
twanmul
U
EU-MDR: complicated supply chain
UNIJP
Jan 14, 2021
Replies
0
Views
88
Jan 14, 2021
UNIJP
A
Aesthetic products / indication
Ana Karoline
Jan 12, 2021
Replies
6
Views
176
Jan 14, 2021
Raisin picker
M
Clinical Evaluation Benchmark vs. Equivalent
mf389
Jan 6, 2021
Replies
2
Views
187
Jan 13, 2021
mf389
C
EU MDR - Annex II 6.1 Pre-clinical and clinical data
Cybel
Jan 12, 2021
Replies
4
Views
160
Jan 13, 2021
Cybel
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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