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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
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News
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About Us
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Contact Details
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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
NEWS
News in Brief
EU Artificial Intelligence Act final text agreed to by Parliament Committees
April 14, 2024
News in Brief
Availability swissdamed and new negotiations between the EU and Switzerland
April 5, 2024
Important Notice
European harmonised standards to be without charge
March 17, 2024
News in Brief
EU Data Act causes difficulties for medical device manufacturers
March 14, 2024
News in Brief
MDCG published guidance on EMDN code updates and clinical investigation plans
March 13, 2024
News in Brief
Potential applicability of Regulation (EU) 2023/1115
March 12, 2024
News in Brief
Revised product liability directive
March 9, 2024
Important Notice
Language requirements overview for the Union market
February 14, 2024
News in Brief
MDCG published device specific vigilance guidance
February 8, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed in the pipeline
February 7, 2024
Important Notice
EU’s first reference laboratories for high-risk Class D IVDs
January 14, 2024
News in Brief
Update to MDCG 2021-27 on importer and distributor roles
January 12, 2024
News in Brief
European Commission publications update on clinical investigations and annex XVI products
January 11, 2024
News in Brief
Manufacturers must act now to satisfy IVDR
December 4, 2023
News in Brief
AI significant in October regulatory discussions
December 1, 2023
News in Brief
EU rules for device software working with hardware
November 29, 2023
News in Brief
European Commission publications update
November 15, 2023
Important Notice
EU medical device industry faces further delays related to EUDAMED
November 7, 2023
News in Brief
Is a centralised governance agency for medical devices feasible?
November 1, 2023
News in Brief
European Commission publishes third revision of the borderline manual
October 10, 2023
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