EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
L
EU MDR GSPR 11.1 (c)
Replies
4
Views
214
Leona
L
L
MDD Certificate Extension for Procedure Packs
Replies
0
Views
129
Lia000
L
J
Responsibilities of Authorized Representative EU
Replies
7
Views
3K
CraigRegulatory
C
Rambo
Raw Materials Suppliers to EU medical device mfrs.
Replies
4
Views
234
Rambo
Rambo
I
UDI and EAN
Replies
3
Views
177
Cybel
C
J
UDI-DI does it always have to use the manufacturers GTIN?
Replies
8
Views
403
Billy Milly
B
Ed Panek
Understanding Latest MDR Notified Body Report
Replies
1
Views
173
dgrainger
dgrainger
P
How to deal with documentation requirements MDD/MDR under 2023/607
Replies
7
Views
392
EmiliaBedelia
E
T
UDI-DI and level of packaging
Replies
5
Views
427
Cybel
C
M
Are "recommendations" part of MDSW?
Replies
5
Views
380
MarRz
M
M
IEC 62366 Hazard-related Use Scenario vs FDA Critical Task
Replies
5
Views
1K
EmiliaBedelia
E
B
Notified Body changed the submission deadlines for NC, CAPA Plans
Replies
7
Views
293
Philip B
P
M
Does my "new" assay require a clinical study? or will a reference interval study suffice? in Japan Medical Device Regulations.
Replies
0
Views
109
Mike W
M
KiraKiwaKilowatt
AFAP principe in Supplier pFMEA
Replies
4
Views
218
yodon
Y
P
All Post-marketing studies = PMCF?
Replies
1
Views
404
VI Me
V
You must log in or register to post here.
Top Bottom