EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
FAQs
Marc
Regulation (EU) 2017/745 of the European Parliament
2
Replies
12
Views
4,887
Watchcat
Discussions
K
EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device;
Replies
1
Views
36
shimonv
M
MDR EU Distributor for our CE Mark product in the for Netherlands
Replies
6
Views
134
mickey
R
Requirements for MDR Article 22 Systems
Replies
1
Views
48
dgrainger
M
Clinical Evaluation Plan vs. PMCF Plan
2
Replies
19
Views
994
Weeder
R
Clinical evaluation without clinical data - MDR Article 61(10)
Replies
6
Views
475
Weeder
H
EU MDR Economic Operator notifications?
Replies
1
Views
61
shimonv
R
Shall a new UDI-DI be required when stand-alone software device's version is updated?
Replies
1
Views
89
monoj mon
P
Transitioning to the EU MDR
Replies
9
Views
853
Weeder
D
Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020?
Replies
3
Views
150
Raisin picker
P
UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications?
Replies
8
Views
859
Kuldeep Singh
K
Class III Kit Box - Are translations mandatory under EU MDR?
Replies
4
Views
107
chris1price
A
EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state
Replies
7
Views
734
SylvieS
S
Importer definition
Replies
0
Views
90
sbosnl
B
Herbal ingredients MDR
Replies
0
Views
68
Ben S UK
A
MDR GSPR Checklist wanted
Replies
3
Views
369
Raisin picker
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