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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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Download Section
Supportive Information
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News
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About Us
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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
Month:
June 2020
News in Brief
Relocation of the European Commission website on medical devices
June 30, 2020
COVID-19
,
News in Brief
European Commission guidance on surgical masks
June 29, 2020
MDR
,
News in Brief
European Commission’s device standardisation request rejected
June 23, 2020
MDR
,
News in Brief
Updated timetable for Eudamed
June 7, 2020
Important Notice
,
MDR
Clinical evaluation and equivalence – using literature under the MDR
June 5, 2020
IVDR
,
MDR
,
News in Brief
New MDR and IVDR guidance documents published by MDCG and MedTech Europe
June 1, 2020