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
15K
KMohan27
K
Discussions
L
Post-market surveillance
Replies
0
Views
48
ltshambu
L
G
Notified body change
Replies
8
Views
215
QARAM
Q
B
Product name change - is this considered as a significant change under EU MDR?
Replies
5
Views
373
Cybel
C
M
IVD Collection Ki
Replies
2
Views
80
MarRz
M
Y
How to manage OEM under EU-MDR regulation
Replies
4
Views
199
yzl1018
Y
N
Looking for a recommendation for an EU MDR Importer
Replies
3
Views
1K
Nichole F
N
D
MDR transition period - extension letter: practical questions
Replies
4
Views
134
Sinus Tarsi
S
Clueless One
Does MDD Cert extend to September if you lodge the application?
Replies
6
Views
168
Clueless One
Clueless One
R
MDR Clinical Evaluation Plan
2
Replies
10
Views
2K
Ed Panek
Ed Panek
N
EU MDR Class I - Usability evidence needed?
Replies
4
Views
364
Ed Panek
Ed Panek
V
Pre-market vs post-market clinical investigation
Replies
9
Views
291
katezhang
K
D
Extending shelf life - Overlabelling existing products
Replies
2
Views
126
DrFergal
D
X
EUDAMED and 2 ARs
Replies
0
Views
119
Xoowoxo
X
R
SaMD and post market surveillance of users
Replies
4
Views
159
shimonv
shimonv
T
MDR - Rule 11 Software class I
Replies
9
Views
334
yodon
Y
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