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
8,764
KMohan27
Discussions
T
CE-IVD mark on packaging
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0
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19
Tanja S
S
PSUR - MDR First Submission Requirement?
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8
Views
864
Ed Panek
I
France clinical trial requirements
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1
Views
71
Vero972
M
Is there a way to obtain redacted copies of IFU from a different manufacturer?
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2
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114
dgrainger
S
Device with different options for a sub-component - CE marking implications
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2
Views
82
StephE
S
Clinical Evaluation of equivalent device
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4
Views
103
dgrainger
M
Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD
Replies
4
Views
424
Marc-ita
Aymaneh
Summary of safety and performance (SSP) IVDR 2017/746
Replies
1
Views
77
yodon
D
Re-labeler - audit the supplier
Replies
2
Views
145
Daliane
B
MDR Technical Structure
Replies
3
Views
140
Mikilk
L
MedTech Europe IVDR Update
Replies
0
Views
82
LUFAN
J
EU equivalent to Clinical Decision Support Software
Replies
3
Views
153
dgrainger
JoCam
On-product labels for Medical Devices
Replies
3
Views
168
Billy Milly
S
Medical Device - Technical Documentation structure
Replies
1
Views
133
Azhar Anwar
L
UDI-DI - Device will be sold by itself in a box
Replies
2
Views
185
med_cert
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