EU Medical Device Regulations

The 3 Medical Device Directives and other applicable regulations related to Medical Devices in the EU (European Union).
FAQs
J
EU MDR getting closer - Special offer for Elsmar members 10/2020
Replies
9
Views
437
JakobAAA
Marc
Regulation (EU) 2017/745 of the European Parliament
2
Replies
12
Views
5,639
Watchcat
Discussions
D
MDR and Summary Technical Documentation Files
2
Replies
14
Views
10,149
Kuldeep Singh
S
Classification of a product according to MDR
Replies
1
Views
63
planB
A
What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you?
Replies
3
Views
160
Awadine
L
Classification under MDR
Replies
1
Views
77
Raisin picker
P
New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices?
Replies
0
Views
54
PG Ltd
JoCam
EU Authorised Representative - Label
Replies
0
Views
62
JoCam
I
Interpretation of the MDR GSPR 23.4 (u)
Replies
2
Views
126
monoj mon
K
Biological indicator system classification under MDR
Replies
2
Views
136
koferong
N
Chemical Testing on Medical Devices - Solutions in a container closure system (bag)
Replies
1
Views
111
planB
L
'Distributor' definition & MDR/MSR relationship
Replies
1
Views
88
L_O_B
shimonv
Checklist for MDD to MDR gap analysis
2
Replies
18
Views
15,433
Seekingknowledgee
M
Can someone share a scrubbed version of Clinical Evaluation Plan (CEP)
Replies
4
Views
851
Raisin picker
T
Implications on the Legal Status of the "Declaration of Conformity"
Replies
8
Views
3,010
Haresh
JoCam
Rental, service & installation - regulatory requirements
Replies
2
Views
137
JoCam
B
Embossing ingestible devices
Replies
1
Views
87
chris1price
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