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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).

FAQs
Marc
  • Sticky
Regulation (EU) 2017/745 of the European Parliament
Replies
0
Views
349
Marc
Discussions
N
Medical Device Re-Classification
Replies
2
Views
64
ncase
S
Non-significant notice of change to notified body
Replies
2
Views
87
shimonv
M
Technical File (STED) labelling - When you compile tech files do we have to include all the product labels?
Replies
2
Views
152
yodon
S
Informational New guidance documents about EUDAMED - April 2019
Replies
1
Views
76
yodon
M
IAS (USA) Accreditation with IAF for ISO 13485 Logo Confusion
2
Replies
10
Views
771
halosenthil
J
Qualification of a Software as a Medical Device (SaMD) guidance under MDR
Replies
8
Views
218
dgrainger
C
Access to Technical Documentation - MDR Chapter VI Article 61
Replies
3
Views
110
pkost
E
Types of nonactive Medical Device implants - What is the origin of this codification?
Replies
6
Views
3,029
pkost
W
PMCF (Post-Market Clinical Followup) vs PMCF studies
2
Replies
18
Views
2,842
Brainy_NE
V
"Manufacturer Symbol on Device is missed due to space constraint" EU requirement
2
Replies
11
Views
313
Ellison
M
How is Class I Medical Device Compliance Enforced?
Replies
4
Views
86
dgrainger
dgrainger
MHRA guidance on Virtual manufacturing - version 2
Replies
0
Views
50
dgrainger
M
Scrubbed version of a labeling procedure that is MDR compliant wanted
Replies
3
Views
164
MDRexpert
SteveK
Post Market Surveillance SOP - Word Version
2 3 4
Replies
38
Views
26,382
MDRexpert
N
How to obtain Own Brand Label (OBL) CE Marking?
2
Replies
18
Views
1,928
Shonver
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