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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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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).
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FAQs
Sticky
Regulation (EU) 2017/745 of the European Parliament
Marc
Dec 13, 2018
2
Replies
13
Views
14K
Jun 15, 2021
KMohan27
K
Discussions
T
Implant Card for Viscosupplements
Talia
Thursday at 8:40 AM
Replies
2
Views
81
Today at 4:40 AM
Talia
T
M
Is there an IVDR requirement that says your predicate must follow the most current WHO reference standard?
Mike W
Thursday at 3:39 PM
Replies
1
Views
53
Yesterday at 6:08 AM
chris1price
MDR 2023 updates not enough?
Ed Panek
Sep 14, 2023
Replies
3
Views
161
Thursday at 9:17 AM
Ed Panek
S
MDD Certificate extension according to 2023/67 MDR extension
Szona
Apr 21, 2023
Replies
8
Views
518
Thursday at 3:33 AM
Feninaar
P
Classification of software needed?
Pzimmermann92
Monday at 9:10 AM
Replies
7
Views
141
Wednesday at 8:40 AM
Tidge
T
P
CE Marking - Turkey & European Authorized Representative - Class IIa Medical Devices
Pauling
Feb 5, 2010
Replies
6
Views
6K
Tuesday at 12:41 PM
EmiliaBedelia
E
M
PRRC liability transfer
MarRz
Monday at 9:19 AM
Replies
4
Views
118
Tuesday at 4:16 AM
shimonv
T
Clinical benefits in intended purpose?
TomQA
Sep 15, 2023
Replies
5
Views
148
Tuesday at 4:15 AM
TomQA
T
M
Importer or not?
Marc Benet Pozo
Sep 8, 2023
Replies
1
Views
141
Monday at 7:08 AM
koulidis
K
A
SW Classification - Documentation software for steam sterilizer devices. class I, IIA or not even a MDSW?
AlexisRuiz2772
Sep 5, 2023
Replies
8
Views
208
Monday at 1:19 AM
AlexisRuiz2772
A
A
IFU physical copy as a part of product package
appivj
Aug 17, 2023
Replies
2
Views
141
Sep 15, 2023
dgrainger
G
Correspondence MDR requirements / standard paragraphs
Galac
Aug 18, 2023
Replies
6
Views
266
Sep 15, 2023
DanMann
D
B
Generalizing Product Name for Medical Device with multiple names.
bolesen
Sep 14, 2023
Replies
1
Views
85
Sep 15, 2023
Cybel
C
C
Identification of standards in GSPRs
CBGus
Sep 15, 2023
Replies
1
Views
68
Sep 15, 2023
Billy Milly
B
M
Need help understanding how language in your intended use can change an IVD classification, per recommendation of a NB
Mike W
Sep 13, 2023
Replies
1
Views
83
Sep 14, 2023
dgrainger
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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