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CE Marking Medical Devices
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Certificates of Free Sale
OEM – Private Labeling
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CE Consulting Environmental Requirements – WEEE / RoHS
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European Authorized Representation for Manufacturers of Medical Devices
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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
Search results
News in Brief
Most Important Changes – Regulation (EU) 2017/745 on Medical Devices (MDR)
July 17, 2019
News in Brief
Most Important Changes – Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
July 16, 2019
The mdi Europa Online Library
July 5, 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
Quality Assurance Agreements (QAA)
June 11, 2019
News in Brief
European Commission Confident that the MDR and the IVDR are on Track
May 30, 2019
News in Brief
The World Health Organisation’s (WHO) New Draft Guideline
May 28, 2019
mdi Europa
May 24, 2019
Important Notice
,
News in Brief
Device Registration and Legacy Devices
April 2, 2019
Brexit
Details about the Regulation of Medical Devices in Case of No-Deal Brexit
February 28, 2019
Brexit
Brexit Key Challenges – a Brief Case Study
February 15, 2019
CE Marking
,
MDR
Technical Documentation Requirements under the MDR – a Case Study
January 14, 2019
CE Consulting
,
IVDR
,
MDR
Notified Body Selection and Change
December 15, 2018
News in Brief
Why is a Clinical Evaluation so Important?
December 11, 2018
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