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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
rob73
Harmonised Standards on DoC (Declaration of Conformity)
Replies
8
Views
3,332
Pads38
T
Harmonized Standard Compliance Question
Replies
5
Views
1,541
Ron Boumans
O
Harmonized standard of EU---EN 60601-2-10:2000/A1:2001
Replies
1
Views
1,066
Marcelo Antunes
M
Harmonized standards vs. EN ISO References
Replies
5
Views
1,622
Ronen E
T
Has NB-MED 2.5.2-Rec 2 Version 8 been withdrawn?
2
Replies
10
Views
8,051
SteveK
B
Health Informatics ISO 11073 - Centrifuge Device Requirements
Replies
1
Views
1,459
Michael Malis
S
Help with EU Medical Device Vigilance Reporting Requirements
Replies
0
Views
976
samtam
S
Help with Massage Device Classification
Replies
2
Views
1,403
samuelson
F
High Level Disinfection Risk - Neonatal CPAP Device
Replies
1
Views
1,332
MIREGMGR
E
Horizontal and Vertical Standards - Definitions in EU Technical File - ER checklist
Replies
1
Views
7,907
rob73
S
How Directive 2007/47/EEC will affect Medical Devices industries?
Replies
3
Views
4,398
sharadmshukla
S
How do I create a Technical File for a Class IIa Medical Device
Replies
4
Views
5,873
Al Rosen
J
How do you Create SOPs for Multiple Authorities?
Replies
8
Views
1,565
insect warfare
E
How do you monitor Medical Device Off-Label use by Customers & Medical Professionals
Replies
5
Views
1,480
Ronen E
SK13485
How does the eMDVR works? To Whom all should the MDV to be reported?
Replies
6
Views
785
SK13485
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