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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
Regulation (EU) 2017/745 of the European Parliament
Replies
0
Views
1,060
Marc
Discussions
T
Trend Reporting under the EU MDR
Replies
4
Views
212
Marcelo Antunes
C
Can we be our own EU authorised representative?
2 3
Replies
20
Views
1,129
Lavaux
N
Regular meetings with Notified Body
2
Replies
12
Views
296
Marc
L
Labels under MDR regulation
Replies
2
Views
73
Lavaux
P
UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications?
Replies
4
Views
237
Krishna Priya T
K
Intended Use-Class I Self Certified - Intended Use and Indications for Use statements
Replies
1
Views
68
Ronen E
K
Implant Card - Full Manufacturer's Address - Space issues
Replies
4
Views
60
dgrainger
D
Software as an accessory to a Class I medical device
Replies
4
Views
104
DinaK
I
2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website
Replies
9
Views
664
Jean_B
D
MDR 2017/745 Classification Guide
Replies
5
Views
157
Devices48
K
EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules?
Replies
2
Views
60
Watchcat
C
If it's not a custom-made medical device... What is it? Clinician requests
2
Replies
11
Views
439
chris1price
A
Please explain MDR Rule 11 to me
2 3 4 5 6 7
Replies
67
Views
1,265
kreid
K
Medical Device Symbol(s) on Accessories
2 3
Replies
26
Views
1,578
Smileyk
N
Non traumatic edge - Remark in some of my company drawings
Replies
1
Views
71
Ronen E
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