EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
FAQs
Marc
  • Sticky
Regulation (EU) 2017/745 of the European Parliament
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0
Views
801
Marc
Discussions
K
EU MDD Class I Device market access / certification after 26th May 2020
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5
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63
Watchcat
A
What is a Terminally Sterilized medical device?
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2
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74
Sidney Vianna
JoCam
Medical Device Software - Apps which can control medical devices
2
Replies
11
Views
1,311
Ronen E
Watchcat
Four NBs now designated under the MDR - August 2019
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5
Views
143
Watchcat
SK13485
What are Regional or National Device Registries for Medical Devices?
2
Replies
10
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1,093
Watchcat
R
PMCF plan to justify that our product not require PMCF study
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2
Views
176
Watchcat
R
Interesting Topic Interesting view of EU Authorised Representative under MDR
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3
Views
117
Ronen E
M
EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required
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3
Views
155
M.R.Falco
T
Translation of IFUs and software by Distributor
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1
Views
52
shimonv
J
IVD CE transfer to another manufacturer
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4
Views
52
Joonseok
T
Product Labeling - Modified the name of one of our products
Replies
5
Views
133
dgrainger
xcanals_tecno-med.es
Qualification of sterilization indicators as medical devices with the EU MDR 2017/745
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5
Views
229
dgrainger
V
Informational EMA - Quality requirements for drug-device combinations
Replies
0
Views
55
v9991
C
CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing
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5
Views
116
chris1price
J
MEDDEV 2.12/1's new MIR & IMDRF terms & codes (IMDRF Annex)
Replies
1
Views
182
yodon
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