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
12
Views
7,609
Watchcat
Discussions
J
Warehouse temperature and humidity control
Replies
7
Views
283
dwperron
M
Addition of IFU on local language by distributor - Article 16?
Replies
0
Views
44
MDRResearcher
A
UDI for product already packed up
Replies
0
Views
38
Armando_C
K
Classification Rationale for class 1
Replies
2
Views
85
Highground
S
Eudamed data fields
Replies
0
Views
47
Sullen-gent
M
Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI?
Replies
2
Views
105
Cybel
R
Products not within the MDR grace period
Replies
1
Views
109
KShaw
L
MDD Definition of Address as it applies to Medical Device Labeling
2 3
Replies
21
Views
14,501
wooddragon
Y
Human Grading SW
Replies
1
Views
78
KShaw
T
Post-Market Surveillance Plan - Requirements outlined in Annex III (1.1b)
Replies
3
Views
1,229
StepPCHen
P
EU MDR Translation of Product Name
Replies
3
Views
365
chris1price
JoCam
Software Translation under MDR requirements
Replies
6
Views
1,356
Annoula
shimonv
MDR transition checklist
Replies
0
Views
130
shimonv
K
Re-packaging under MDR
Replies
0
Views
59
koulidis
E
Language requirement DoC
Replies
3
Views
103
Cybel
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