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CE Marking Medical Devices
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European Authorized Representation for Manufacturers of Medical Devices
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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:
Performance Evaluation
News in Brief
Templates on hand for sponsors of IVD performance studies
February 15, 2023
News in Brief
News on useful publications: MDCG borderline manual and bsi white paper on performance evaluations
October 13, 2022
Important Notice
,
IVDR
IVDR clinical evidence
February 3, 2022
News in Brief
The IVDR and performance evaluation studies
July 8, 2021
Important Notice
,
IVDR
Performance Evaluation for IVD Medical Devices
October 28, 2019