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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FAQs
Marc
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Regulation (EU) 2017/745 of the European Parliament
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0
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220
Marc
Discussions
J
Medical Device Vigilance decision tree FORM - Please share yours
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6
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182
Jnks_Meddev
H
Critical Supplier Agreement acc. to NBOG 2010-1 Annex II
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4
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127
planB
F
Irradiation Sterilization Validation Maximum Dose - VDmax 25 method (ISO 11137)
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2
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94
planB
M
Entering the Italian Market - Implantable Medical Device
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0
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37
Macie
J
Marketing and promotional materials - EU and MDR Specific
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6
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126
Jnks_Meddev
M
UDI labeling MDR requirement for reusable medical device accessories
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9
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233
Edward Reesor
J
CE Marking and Brexit - Product shipped to a distributor prior to the March deadline
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2
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71
JoshuaFroud
S
Medical device CER (clinical evaluation report) according to MDR
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2
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117
Rincewind
J
Control of Medical Device Marketing and Promotional Materials - EU regulation
2
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12
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252
Jnks_Meddev
M
CE mark validity after Brexit, 29th March '19
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6
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205
AliGuff
C
Person Responsible for Regulatory Compliance
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1
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125
moounir
moounir
Medical Device Nomenclature - Free of Charge
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3
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142
Marcelo Antunes
S
Authorized (EC) Representative Contract and SOP
2
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12
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2,287
somashekar
J
Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer?
2
Replies
11
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2,877
PearlKetchup
J
EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances
Replies
2
Views
178
Jean_B
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