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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
Today at 6:24 AM
Replies
0
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38
Today at 6:24 AM
Marc
Discussions
MDR Conformity Assessment for a Class 2a device - Production Quality Assurance
chris1price
Today at 9:52 AM
Replies
0
Views
24
Today at 9:52 AM
chris1price
T
EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties)
Thulasidharan
Today at 3:56 AM
Replies
0
Views
37
Today at 3:56 AM
Thulasidharan
J
Virtual Manufacturer and CE Marking
jesupesu
Nov 1, 2018
Replies
7
Views
259
Yesterday at 1:12 PM
DMLqms
R
Sample size for clinical validation/investigation
RA Lille
Dec 4, 2018
Replies
4
Views
134
Yesterday at 8:52 AM
RA Lille
N
Will an FDA UDI be compatible with a European MDR UDI?
Nancylove
Oct 26, 2018
Replies
5
Views
254
Tuesday at 10:51 AM
snowball852
C
Substance based Medical Device Classification under MDR - Rule 21
ciccina
Jan 21, 2018
Replies
7
Views
1,957
Tuesday at 9:06 AM
TycoSQR
T
Risk Management Report as per MDR Requirements
Thulasidharan
Friday at 8:10 AM
Replies
3
Views
112
Monday at 6:42 AM
Marcelo Antunes
S
Clinical evaluation for a class IIa medical device - EU MDR Requirements
Susan
Dec 5, 2018
Replies
3
Views
169
Monday at 6:41 AM
Marcelo Antunes
B
EU conformity assessment - Certify to MDD or MDR?
bookish
Dec 6, 2018
Replies
3
Views
117
Friday at 8:40 AM
Marcelo Antunes
T
Clarification on MDR - Article 18(d) - Implant Card
Thulasidharan
Nov 30, 2018
2
Replies
13
Views
239
Friday at 3:09 AM
Marcelo Antunes
C
Do Distributors need to register with competent authorities in the EU?
Cuffern
Nov 29, 2018
Replies
2
Views
101
Dec 6, 2018
Marcelo Antunes
F
What directives/regulations apply to Analyte Specific Reagents (ASRs) in EU
fondantcookie
Dec 5, 2018
Replies
0
Views
38
Dec 5, 2018
fondantcookie
Medical Device News
Brexit - Withdrawal Agreement and Political Declaration laid before Parliament following political agreement.
Marcelo Antunes
Nov 26, 2018
Replies
4
Views
162
Dec 3, 2018
John Broomfield
K
Is minimum repair or replace guarantee period for medical devices in EU the same as consumer guarantee law of 2 years?
krystle
Nov 29, 2018
Replies
5
Views
133
Dec 3, 2018
supadrai
R
Pressure energy - Essential Requirements (MDD/MDR)
Rincewind
Nov 29, 2018
Replies
2
Views
82
Nov 30, 2018
dgrainger
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Regulations
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