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
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:
UDI
Important Notice
EUDAMED Workshop – Preparing for Compliance
April 8, 2025
Important Notice
Upcoming UDI labeling requirements for Medical Devices
April 7, 2025
News in Brief
Additional updates from the European Commission
December 9, 2024
Important Notice
Q&A document on the gradual rollout of EUDAMED available
November 30, 2024
Important Notice
Efficient support for medical device manufacturers: mdi Europa and the EUDAMED database
September 22, 2024
News in Brief
European Commission publications update
November 15, 2023
IVDR
,
MDR
,
News in Brief
New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
July 4, 2021
IVDR
,
MDR
,
News in Brief
Updated Q&A document on MDR and IVDR UDI requirements from the European Commission
August 12, 2020
MDR
,
News in Brief
Updated timetable for Eudamed
June 7, 2020
Important Notice
,
News in Brief
Device Registration and Legacy Devices
April 2, 2019