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CE Marking 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:
EUDAMED
Important Notice
Amending Regulation (EU) 2024/1860 published in the OJEU
July 10, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed takes last hurdle
May 31, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed about to be finally adopted
April 26, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed in the pipeline
February 7, 2024
Important Notice
Different options for IVD medical devices until Eudamed becomes fully operational
September 2, 2022
Important Notice
,
IVDR
,
MDR
EUDAMED update on timelines
April 10, 2022
Important Notice
,
IVDR
,
MDR
European Commission EUDAMED website expanded
December 6, 2021
Important Notice
,
IVDR
,
MDR
EUDAMED UDI/Devices and NBs/Certificates modules now live
October 6, 2021
IVDR
,
MDR
,
News in Brief
Guidance on legacy devices regarding Eudamed
May 3, 2021
Important Notice
,
IVDR
,
MDR
Updated EUDAMED implementation dates
April 1, 2021
Important Notice
,
IVDR
,
MDR
MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality
March 15, 2021
IVDR
,
MDR
,
News in Brief
Voluntary registration with EUDAMED database – industry fears duplicate registrations
January 23, 2021
IVDR
,
MDR
,
News in Brief
New website on actor registration in EUDAMED 3 available
October 29, 2020
IVDR
,
MDR
,
News in Brief
Get ready for the economic operator registration in EUDAMED
October 9, 2020
IVDR
,
MDR
,
News in Brief
EUDAMED economic operator registration module available as of December 2020
September 16, 2020
News in Brief
Early access to Single Registration Numbers (SRN)
December 16, 2019
Important Notice
,
News in Brief
News on EUDAMED
November 7, 2019
Important Notice
,
News in Brief
Device Registration and Legacy Devices
April 2, 2019