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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
UK & Swiss Services
UK Responsible Person (UKRP)
Swiss Authorized Representative
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