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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
Tag:
Guidance Documents
News in Brief
The World Health Organisation’s (WHO) New Draft Guideline
May 28, 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
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