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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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Regulation (EU) 2017/745 of the European Parliament
Marc
Dec 13, 2018
2
Replies
13
Views
15K
Jun 15, 2021
KMohan27
K
Discussions
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Debugging on site?
Minnie
Today at 8:51 AM
Replies
2
Views
50
Today at 12:56 PM
Ron Rompen
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Declaration of conformity
Noha Ahmed
Sunday at 9:52 AM
Replies
2
Views
137
Monday at 10:50 AM
EmiliaBedelia
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S
MDR Technical File for more than 1 medical device
sophgira
Thursday at 9:22 AM
Replies
3
Views
191
Monday at 5:44 AM
sophgira
S
B
Compliance obligation with ISO/IEC 27001:2022
bimeri
Apr 9, 2024
Replies
2
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127
Apr 10, 2024
Ed Panek
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MDR Clinical Evaluation Plan
Reg1000
Aug 3, 2022
Replies
7
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2K
Apr 7, 2024
Lissa
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EU MDR GSPR 11.1 (c)
Leona
Apr 4, 2024
Replies
4
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143
Apr 6, 2024
Leona
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MDD Certificate Extension for Procedure Packs
Lia000
Apr 5, 2024
Replies
0
Views
75
Apr 5, 2024
Lia000
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Responsibilities of Authorized Representative EU
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Jul 8, 2013
Replies
7
Views
3K
Apr 4, 2024
CraigRegulatory
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Raw Materials Suppliers to EU medical device mfrs.
Rambo
Apr 1, 2024
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4
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175
Apr 3, 2024
Rambo
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UDI and EAN
ines ha
Apr 2, 2024
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3
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123
Apr 3, 2024
Cybel
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UDI-DI does it always have to use the manufacturers GTIN?
JP12345
Mar 27, 2024
Replies
8
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260
Apr 3, 2024
Billy Milly
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Understanding Latest MDR Notified Body Report
Ed Panek
Apr 1, 2024
Replies
1
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125
Apr 2, 2024
dgrainger
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How to deal with documentation requirements MDD/MDR under 2023/607
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Mar 28, 2024
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7
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201
Apr 1, 2024
EmiliaBedelia
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MDR - Rule 11 Software class I
TomQA
Mar 27, 2024
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7
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201
Mar 28, 2024
mjamesl
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UDI-DI and level of packaging
TomQA
Feb 21, 2024
Replies
5
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338
Mar 28, 2024
Cybel
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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