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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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EU Country Specific Medical Device Registration Requirements
RAspecialist
Nov 24, 2010
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4
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33
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Nov 5, 2019
Philip B
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UDI placement - Packaging levels
MedicalDevice
Oct 28, 2019
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2
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2K
Nov 4, 2019
MedicalDevice
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NHS exemption - Benefits versus expectations in UK NHS service
James
Nov 1, 2019
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0
Views
737
Nov 1, 2019
James
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MDR Legacy Medical Device Labeling compliance timeline
Martin Med
Oct 28, 2019
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3
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2K
Oct 29, 2019
Marcelo
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EU MDR - Annex II 3b - What documents fall under this requirement?
MDRexpert
Oct 24, 2019
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3
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1K
Oct 26, 2019
yodon
Y
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UDI Requirments Gap Analysis - EU MDR vs FDA CFR
lalvares1
Oct 24, 2019
Replies
8
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3K
Oct 26, 2019
shimonv
J
Machinery Directive vs. MDD Comparison Matrix wanted
jinglot
Nov 16, 2016
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6
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4K
Oct 25, 2019
lama01
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D
MDR 2017/745 Classification Guide
Devices48
Oct 12, 2019
Replies
8
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3K
Oct 25, 2019
dgrainger
Z
Role of economic operators (EO) post the EU MDR Date of application in May 2020
zuhus
Oct 24, 2019
Replies
1
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1K
Oct 24, 2019
Marcelo
M
J
Custom made medical devices - Wheelchairs
James
Oct 12, 2019
Replies
6
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1K
Oct 24, 2019
dgrainger
Y
CE Mark - Placing the CE mark on medical device labels
Yael Klein
Oct 22, 2019
Replies
2
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1K
Oct 23, 2019
Yael Klein
Y
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MDR review process by notified body - How many steps exist in the review process
Nono
Oct 22, 2019
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0
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1K
Oct 22, 2019
Nono
N
CAPA against Notified Body?
Ed Panek
Oct 21, 2019
Replies
5
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1K
Oct 21, 2019
Watchcat
L
Label Content Requirements under MDR regulation
Lavaux
Oct 16, 2019
Replies
5
Views
1K
Oct 18, 2019
Asia78
A
Country of origin - Made in EU or Made in Finland?
MDD_QNA
Oct 18, 2019
Replies
1
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1K
Oct 18, 2019
twanmul
T
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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