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CE Marking Medical Devices
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European Authorized Representation for Manufacturers of Medical Devices
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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
UK & Swiss Services
UK Responsible Person (UKRP)
Swiss Authorized Representative
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
Swiss Medical Device Manufacturers Under Pressure
April 26, 2019
News in Brief
Draft Policy on Remaining Shelf-Life for Medical Products
April 17, 2019
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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