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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
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Complete Download Section mdi Europa
October 20, 2024
News in Brief
EU on proposed regulations for seven high-risk IVD test categories
October 2, 2024
Important Notice
The medical technology sector faces significant changes due to the EU’s upcoming PFAS restriction
September 9, 2024
Important Notice
When is a medical device impacted by the AI Act?
August 6, 2024
Important Notice
AI Act published in OJEU
July 12, 2024
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
News in Brief
Could the AI Act result in the limited availability of medical technologies?
April 21, 2024
News in Brief
EU Artificial Intelligence Act final text agreed to by Parliament Committees
April 14, 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
Potential applicability of Regulation (EU) 2023/1115
March 12, 2024
News in Brief
Revised product liability directive
March 9, 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
European Commission publications update
November 15, 2023
News in Brief
The European Commission’s AI Act now in final negotiation phase
August 24, 2023