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CE Marking Medical Devices
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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
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
Tag:
UDI
News in Brief
Additional updates from the European Commission
December 9, 2024
Important Notice
Q&A document on the gradual rollout of EUDAMED available
November 30, 2024
Important Notice
Efficient support for medical device manufacturers: mdi Europa and the EUDAMED database
September 22, 2024
News in Brief
European Commission publications update
November 15, 2023
IVDR
,
MDR
,
News in Brief
New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
July 4, 2021
IVDR
,
MDR
,
News in Brief
Updated Q&A document on MDR and IVDR UDI requirements from the European Commission
August 12, 2020
MDR
,
News in Brief
Updated timetable for Eudamed
June 7, 2020
Important Notice
,
News in Brief
Device Registration and Legacy Devices
April 2, 2019