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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
Replies
0
Views
220
Dec 13, 2018
Marc
Discussions
J
Medical Device Vigilance decision tree FORM - Please share yours
Jnks_Meddev
Jan 29, 2019
Replies
6
Views
182
Today at 11:18 AM
Jnks_Meddev
H
Critical Supplier Agreement acc. to NBOG 2010-1 Annex II
htcoztrk
Feb 8, 2019
Replies
4
Views
127
Today at 10:15 AM
planB
F
Irradiation Sterilization Validation Maximum Dose - VDmax 25 method (ISO 11137)
Frodeno
Feb 6, 2019
Replies
2
Views
94
Today at 8:59 AM
planB
M
Entering the Italian Market - Implantable Medical Device
Macie
Yesterday at 6:57 PM
Replies
0
Views
37
Yesterday at 6:57 PM
Macie
J
Marketing and promotional materials - EU and MDR Specific
Jnks_Meddev
Wednesday at 2:27 PM
Replies
6
Views
126
Friday at 10:01 AM
Jnks_Meddev
M
UDI labeling MDR requirement for reusable medical device accessories
mare1
Feb 1, 2019
Replies
9
Views
233
Thursday at 10:46 AM
Edward Reesor
J
CE Marking and Brexit - Product shipped to a distributor prior to the March deadline
JoshuaFroud
Wednesday at 8:06 AM
Replies
2
Views
71
Thursday at 6:12 AM
JoshuaFroud
S
Medical device CER (clinical evaluation report) according to MDR
sebastien
Tuesday at 7:34 AM
Replies
2
Views
117
Wednesday at 10:28 AM
Rincewind
J
Control of Medical Device Marketing and Promotional Materials - EU regulation
Jnks_Meddev
Feb 11, 2019
2
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12
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252
Tuesday at 10:08 AM
Jnks_Meddev
M
CE mark validity after Brexit, 29th March '19
MiamiDM
Feb 4, 2019
Replies
6
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205
Feb 8, 2019
AliGuff
C
Person Responsible for Regulatory Compliance
Cuffern
Feb 4, 2019
Replies
1
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125
Feb 7, 2019
moounir
Medical Device Nomenclature - Free of Charge
moounir
Feb 6, 2019
Replies
3
Views
142
Feb 6, 2019
Marcelo Antunes
S
Authorized (EC) Representative Contract and SOP
scotthowells
May 2, 2017
2
Replies
12
Views
2,287
Feb 6, 2019
somashekar
J
Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer?
Jango
Oct 18, 2017
2
Replies
11
Views
2,877
Feb 4, 2019
PearlKetchup
J
EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances
Jnks_Meddev
Feb 1, 2019
Replies
2
Views
178
Feb 4, 2019
Jean_B
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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