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
2
Replies
13
Views
9,850
KMohan27
Discussions
V
Literature search over how many years?
Replies
1
Views
18
Raisin picker
S
Definition of sterile condition
Replies
4
Views
293
engemerson
C
MDR - Annex II _3. DESIGN AND MANUFACTURING INFORMATION_a
Replies
2
Views
102
TWA - not the airline
B
Software as a Medical Device - Language Requirements
Replies
4
Views
141
indubioush
A
MDR Article 16 Certification of Distributors by a Notified Body?
Replies
2
Views
78
akerenyi
J
PSUR encompassing PMS Report?
Replies
5
Views
151
Philip B
N
Actor registration EUDAMED restricted: got no Email to complete the registration
Replies
6
Views
641
Mga_MD
J
Enough for PSUR to cover product family? (Procedure packs, not the legal manufacturer)
Replies
1
Views
66
Junn1992
K
EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device;
Replies
2
Views
1,465
eccaus
D
Is sampling allowed for MDR Class III products?
Replies
0
Views
67
Daliane
M
EUDAMED Registration tracker
Replies
4
Views
136
Mga_MD
M
CER Review
Replies
2
Views
81
Raisin picker
K
Question on MDR classification
Replies
5
Views
593
Bonebuilder
V
Recommended EU 2017/745 electronic submission format
Replies
3
Views
153
Philip B
D
One Software as Medical Device product or two?
Replies
4
Views
251
doracre
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