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CE Marking Medical Devices
CE Marking
CE Approval
MDR
IVDR
Certificates of Free Sale
OEM – Private Labeling
Technical File Compilation
Declaration of Conformity
CE Consulting Electrical Equipment – EMC / LVD
CE Consulting Environmental Requirements – WEEE / RoHS
EU Authorized Representative
European Authorized Representation for Manufacturers of Medical Devices
EU Authorized Representative Responsibilities
EU Authorized Representative vs. Distributor
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Home
CE Marking Medical Devices
CE Marking
CE Approval
MDR
IVDR
Certificates of Free Sale
OEM – Private Labeling
Technical File Compilation
Declaration of Conformity
CE Consulting Electrical Equipment – EMC / LVD
CE Consulting Environmental Requirements – WEEE / RoHS
EU Authorized Representative
European Authorized Representation for Manufacturers of Medical Devices
EU Authorized Representative Responsibilities
EU Authorized Representative vs. Distributor
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
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News in Brief
News in Brief
Updated Clinical Evaluation Guidance on Comparability
April 8, 2019
Important Notice
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News in Brief
Device Registration and Legacy Devices
April 2, 2019
News in Brief
Guidance on Article 54(2)b of Regulation (EU) 2017/745 on medical devices (MDR)
March 22, 2019
News in Brief
Why is a Clinical Evaluation so Important?
December 11, 2018
News in Brief
Labeling Changes under the Regulation (EU) 2017/745 on medical devices (MDR)
December 4, 2018
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