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
14K
KMohan27
K
Discussions
T
Implant Card for Viscosupplements
Replies
2
Views
81
Talia
T
M
Is there an IVDR requirement that says your predicate must follow the most current WHO reference standard?
Replies
1
Views
53
chris1price
chris1price
Ed Panek
MDR 2023 updates not enough?
Replies
3
Views
161
Ed Panek
Ed Panek
S
MDD Certificate extension according to 2023/67 MDR extension
Replies
8
Views
518
Feninaar
Feninaar
P
Classification of software needed?
Replies
7
Views
141
Tidge
T
P
CE Marking - Turkey & European Authorized Representative - Class IIa Medical Devices
Replies
6
Views
6K
EmiliaBedelia
E
M
PRRC liability transfer
Replies
4
Views
118
shimonv
shimonv
T
Clinical benefits in intended purpose?
Replies
5
Views
148
TomQA
T
M
Importer or not?
Replies
1
Views
141
koulidis
K
A
SW Classification - Documentation software for steam sterilizer devices. class I, IIA or not even a MDSW?
Replies
8
Views
208
AlexisRuiz2772
A
A
IFU physical copy as a part of product package
Replies
2
Views
141
dgrainger
dgrainger
G
Correspondence MDR requirements / standard paragraphs
Replies
6
Views
266
DanMann
D
B
Generalizing Product Name for Medical Device with multiple names.
Replies
1
Views
85
Cybel
C
C
Identification of standards in GSPRs
Replies
1
Views
68
Billy Milly
B
M
Need help understanding how language in your intended use can change an IVD classification, per recommendation of a NB
Replies
1
Views
83
dgrainger
dgrainger
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