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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).
FAQs
Marc
  • Sticky
Regulation (EU) 2017/745 of the European Parliament
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0
Views
571
Marc
Discussions
R
Informational The future of MEDDEV 2.7/1
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1
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53
dgrainger
K
Medical Device Symbol(s) on Accessories
2
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15
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329
Kim B
M
Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind
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4
Views
75
Ronen E
C
MDR Importer/Distributor Definition Questions
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5
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200
Aliken
P
UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications?
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3
Views
84
François
S
Medical Device Software Distribution for a CE-marked medical device via a USB memory stick
Replies
5
Views
137
SKM.Sunil
A
How to manage the QMS system and SOP during the transition from MDD to MDR
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1
Views
95
yodon
M
CEP requirements in MEDDEV 2.7/1, rev 4 and MDR - Are all MEDDEV requirements still applicable?
Replies
7
Views
259
Ronen E
J
Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain
Replies
4
Views
83
Ronen E
S
Dual MDD and MDR certification
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7
Views
210
Sullen-gent
DMLqms
Exporting into the EU from UK after Brexit
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3
Views
198
snowball852
S
IFU on web page - Consequences if the most recent one is not uploaded
Replies
3
Views
96
SANE
M
MDR 2017/745 sterile and non-sterile labeling
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4
Views
100
craiglab
L
Clinical Investigations under MDR
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4
Views
123
lisasolo
A
MDRS Standards Harmonisation - copy of ISO 15223-1
Replies
3
Views
154
craiglab
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