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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
Regulation (EU) 2017/745 of the European Parliament
2
Replies
12
Views
2,359
Watchcat
Discussions
T
Spirometer - Pulmonary Function Testing - ATS/ERS:2005
Replies
5
Views
150
Marc
U
Do we need clinical trial data for Class IIa medical device under MDR
Replies
7
Views
216
Ellison
DMLqms
Material for laboratory use or Medical Device?
Replies
2
Views
70
ScottK
K
Annex XVI Device Transition Timeline under the MDR
Replies
1
Views
90
Ronen E
M
MDR "Common Specifications" (CS) - If not standards, then what?
Replies
2
Views
76
Mark Meer
S
Can medical device labels in EU be bilingual?
Replies
2
Views
106
Philip B
M
Barrier cream classification
Replies
2
Views
110
dgrainger
Watchcat
Input needed from MDR Gurus!
Replies
0
Views
93
Watchcat
B
Procedures for Complaint Handling and Post Market Surveillance
Replies
5
Views
305
kaitybarry
xcanals_tecno-med.es
Qualification of sterilization indicators as medical devices with the EU MDR 2017/745
Replies
7
Views
489
xcanals_tecno-med.es
moounir
Medical Device Nomenclature - Free of Charge? (European Union MDR MDR 2017/745)
Replies
7
Views
878
WAQAR-QMS
MDD_QNA
Accessory or I-don't-know-what-to-call-it-at-this-point
Replies
3
Views
138
MDD_QNA
N
Medical Device Classification under MDR - Rule 21
Replies
4
Views
106
chingyreep
MDD_QNA
We have a device with two intended uses and we want to remove one
2
Replies
14
Views
343
Ronen E
Watchcat
Whatever happened to Eudamed 1.0?
Replies
4
Views
93
Watchcat
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