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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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T
CE mark start date for a device
tiptoe
Dec 13, 2019
Replies
7
Views
1K
Jan 2, 2020
tiptoe
T
G
Selling a CE mark Class I Medical Device in Sweden - Any other requirements?
Gaya123
Mar 3, 2013
2
Replies
13
Views
6K
Dec 23, 2019
WAQAR-QMS
D
Classification of Syringe (nozzle) of needle free injection system.
DEEVH
Dec 16, 2019
Replies
8
Views
3K
Dec 20, 2019
DEEVH
D
A
Components of a medical device - Hardware robotic hand
Asia78
Dec 19, 2019
Replies
3
Views
797
Dec 19, 2019
Ronen E
MDCG guidance on class 1 devices and MDR
rob73
Dec 19, 2019
Replies
0
Views
1K
Dec 19, 2019
rob73
Z
MDD ER 7.5, "phthalate test"? Aspiration tips
zeypzeyn
Dec 12, 2019
Replies
3
Views
1K
Dec 16, 2019
zeypzeyn
Z
S
CE Mark - Classification Confusion
Sera Maya
Nov 25, 2019
2
Replies
12
Views
2K
Dec 12, 2019
Sera Maya
S
M
Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At?
Mark Meer
Dec 6, 2019
Replies
7
Views
4K
Dec 12, 2019
twanmul
T
MEDDEV 2.7/1 rev 4 and MDR - Definition of Description of Principles of operation
FoGia
Dec 9, 2019
Replies
4
Views
5K
Dec 10, 2019
Watchcat
R
Breast Pump under MDR classified as medical device?
Rachute
Dec 5, 2019
Replies
9
Views
5K
Dec 9, 2019
dgrainger
Detachable parts vs Off the Shelf parts
SKM.Sunil
Dec 3, 2019
Replies
8
Views
2K
Dec 6, 2019
yodon
Y
Interesting Discussion
FEDERAL COURT OF AUSTRALIA: Gill v Ethicon Sàrl - Mesh
dgrainger
Dec 6, 2019
Replies
0
Views
1K
Dec 6, 2019
dgrainger
S
Degree of control of distributors - PMS
ShRam
Dec 5, 2019
Replies
2
Views
1K
Dec 6, 2019
RA_QA_Expert
R
M
UDI transition period and implementation
MedicalDevice
Nov 14, 2019
Replies
6
Views
2K
Dec 6, 2019
SKM.Sunil
E
Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR?
eddieuk
Dec 4, 2019
Replies
4
Views
2K
Dec 5, 2019
dgrainger
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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