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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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EU Medical Device Regulations
The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
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How many hours for a NB to review Technical Documentation?
jackakajp
Oct 15, 2021
Replies
6
Views
2K
Oct 18, 2021
Ed Panek
I
Eudamed UDI-Module
itscloud
Oct 11, 2021
Replies
9
Views
1K
Oct 15, 2021
monoj mon
M
Informational
Good news: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation
dgrainger
Oct 14, 2021
Replies
3
Views
1K
Oct 14, 2021
Ed Panek
EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017)
Sam Lazzara
Jun 26, 2017
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5
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5K
Oct 13, 2021
juswis
J
P
Brexit
Germany - Import Medical Device For Clinical Study
Pushpita
Oct 12, 2021
Replies
0
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829
Oct 12, 2021
Pushpita
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M
Article 22 - Include statement in procedure pack?
Martin Med
Oct 12, 2021
Replies
1
Views
649
Oct 12, 2021
chris1price
M
MDR harmonized standards
mf389
Feb 3, 2021
Replies
7
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2K
Oct 11, 2021
the_norwegian
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O
EU MDR labels
Ololo
Sep 5, 2021
Replies
1
Views
781
Oct 8, 2021
Vetty007
V
CE Mark on Kit label AND inner label?
Leigh76
Oct 6, 2021
Replies
1
Views
591
Oct 8, 2021
Sierra
S
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Classification of a container containing a liquified gas
Grit21
Oct 8, 2021
Replies
0
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481
Oct 8, 2021
Grit21
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1 product multiple factories
LouisNL
Oct 7, 2021
Replies
0
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893
Oct 7, 2021
LouisNL
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C
Appendix Z in Harmonised Standards?
Cybel
Dec 18, 2020
2
Replies
15
Views
4K
Oct 7, 2021
Philip B
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Informational
MDCG 2021-24 - Guidance on classification of medical devices
dgrainger
Oct 4, 2021
Replies
0
Views
797
Oct 4, 2021
dgrainger
C
Substance based Medical Device Classification under MDR - Rule 21
ciccina
Jan 21, 2018
2
Replies
10
Views
6K
Oct 1, 2021
Manel Mou
M
Poll
Notified Body Performance Trending Poll
Ed Panek
Sep 30, 2021
Replies
8
Views
930
Oct 1, 2021
chris1price
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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