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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).

Discussions
P
E-Labeling Regulations Draft - Medical Device Electronic Instructions for Use (IFUs)
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0
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2,703
pkost
W
East European NB for MD - How are they when compared with Western NB's?
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6
Views
1,424
Ron Boumans
S
EC Certificate - EC certificates are issued for CE Marking
Replies
6
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7,831
sriramsl
A
EC Certification Process and Time Frame for Own Brand Labeling Medical Devices
Replies
4
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1,542
J0anne
A
EC Technical File DoC (Declaration of Conformity) Content Requirements
Replies
8
Views
5,318
Satch
dgrainger
EC-MDR Information for manufacturers guidance
Replies
1
Views
318
chris1price
J0anne
Effects of Strengthened Surveillance of Notified Bodies in 2015
Replies
1
Views
1,023
Reg Morrison
I
Electrical Medical Device and Entry in US Market
Replies
5
Views
2,285
bio_subbu
E
Electrical safety (battery-powered medical device)
Replies
1
Views
764
Pads38
N
Electronic Instructions for use (eIFU)
Replies
1
Views
290
Pads38
S
Electronic Instructions for Use (IFU) of Medical Devices
2
Replies
10
Views
4,207
rcarrillo888
T
Electronic Package inserts
Replies
6
Views
2,874
Pads38
W
Electrosurgical devices/surgery IFU contraindications
Replies
2
Views
443
Mark Meer
R
Eligibility for Reimbursement of Medical Devices in EU
Replies
1
Views
1,513
Marc
T
EN 1041 or EN 980 - Need Documents Please!
Replies
2
Views
3,620
SteveK
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