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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
Month:
June 2019
Important Notice
,
News in Brief
Guidance on Person Responsible for Regulatory Compliance
June 23, 2019
News in Brief
Guidance on Implant Cards
June 23, 2019
Important Notice
,
News in Brief
Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics
June 14, 2019
News in Brief
BfArM Recommendation on Paclitaxel-coated Stents and Balloons
June 13, 2019
News in Brief
LRQA to Withdraw Notified Body Services
June 13, 2019
News in Brief
Quality Assurance Agreements (QAA)
June 11, 2019
News in Brief
EU Guidance on Quality Rules for Drug-Device Combinations
June 4, 2019
News in Brief
Spain’s Only Notified Body Not Accepting Applications for Certification of New Products
June 3, 2019