EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
FAQs
Marc
  • Sticky
Regulation (EU) 2017/745 of the European Parliament
2
Replies
13
Views
11,785
KMohan27
Discussions
M
MDCG 2022-11
Replies
4
Views
199
Ed Panek
R
Clinical Evaluation - state of the art literature search
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2
Views
279
MDRexpert
Z
Classification according to MDR
Replies
1
Views
128
Jen Kirley
G
MDR DRAFT DoC
Replies
7
Views
188
gabe2jadyn
S
How to deal with customers requesting documents as being in the role of distributor?
Replies
5
Views
382
SANE
M
UKCA
Replies
5
Views
170
Philip B
S
PMS Literature Search
Replies
2
Views
149
Cybel
G
Labeling requirements for REFURBISHED medical devices
Replies
0
Views
83
GGaelle
F
MDR Distributor
Replies
5
Views
215
Cybel
M
IEC 62366 Hazard-related Use Scenario vs FDA Critical Task
Replies
3
Views
151
yodon
dgrainger
Informational Manual on Borderline for MDR/IVDMDR
Replies
6
Views
223
dgrainger
Y
EU MDR Technical Documentation - Defined Review
Replies
1
Views
138
Billy Milly
N
Exempted devices
Replies
2
Views
168
Raisin picker
M
Declaration of conformity MDR
2
Replies
10
Views
316
Malomsoki Gabor
B
"Old" devices - MDCG 2021-25
Replies
3
Views
134
boncki
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