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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).
FAQs
J
  • Sticky
EU MDR getting closer - Special offer for Elsmar members 10/2020
2
Replies
14
Views
1,571
JakobAAA
Marc
  • Sticky
Regulation (EU) 2017/745 of the European Parliament
2
Replies
12
Views
6,490
Watchcat
Discussions
M
MDR, RED and LVD - Should our device comply with them?
Replies
3
Views
418
Dana Kelly
R
MDR & depth of review by NB's
Replies
7
Views
222
ralf90
S
Medical device CER (clinical evaluation report) according to MDR
2
Replies
19
Views
3,736
CanChua
D
Surgical Instrument Tray Classification
Replies
7
Views
487
Asia78
E
Medical Device - CE marking - Local market notifications
Replies
0
Views
63
EliJones
J
Medical Device Vigilance decision tree FORM - Please share yours
2
Replies
15
Views
3,348
Developer_Germany
U
Power supply - Change From 160 to 300 Watts - Significant change?
Replies
0
Views
84
Udirn1
S
EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean?
2
Replies
13
Views
2,401
theresareeb
shimonv
Checklist for MDD to MDR gap analysis
2 3
Replies
21
Views
18,102
Mikilk
D
Deciding whether or not pre-market clinical investigation is required for low risk device
Replies
5
Views
324
DamienL
A
IVD in MDR procedure pack
Replies
2
Views
143
twanmul
U
EU-MDR: complicated supply chain
Replies
0
Views
88
UNIJP
A
Aesthetic products / indication
Replies
6
Views
176
Raisin picker
M
Clinical Evaluation Benchmark vs. Equivalent
Replies
2
Views
187
mf389
C
EU MDR - Annex II 6.1 Pre-clinical and clinical data
Replies
4
Views
160
Cybel
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