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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
UK & Swiss Services
UK Responsible Person (UKRP)
Swiss Authorized Representative
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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
Author:
Oliver Giesemann
Important Notice
European Commission publishes updated version of the Manufacturer Incident Report (MIR)
May 7, 2025
Important Notice
EUDAMED Workshop – Preparing for Compliance
April 8, 2025
Important Notice
Upcoming UDI labeling requirements for Medical Devices
April 7, 2025
Important Notice
Update to MDCG Guidelines for In Vitro Diagnostics
April 4, 2025
News in Brief
New and updated guidance for the MDR and IVDR
March 15, 2025
News in Brief
EU policymakers to retract the proposal on AI liability
March 8, 2025
Important Notice
EC REP to EU REP: A new symbol for European Authorized Representatives
February 14, 2025
Important Notice
Guidance on SARS-CoV-2 test classification and news on EMDN coding
February 6, 2025
News in Brief
The European Union simplifies the management of multinational combination product trials
January 18, 2025
Important Notice
Have your say!!!
January 12, 2025
News in Brief
Implementing regulations on eIFU, well-established technologies and orphan/ pediatric devices in sight
January 11, 2025
News in Brief
Guidance updates from the European Commission and TEAM-NB
January 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
News in Brief
New expert panel review in the context of the PECP
November 28, 2024
Important Notice
Q&A on obligation to inform in case of interruption/ discontinuation of supply chain published
November 12, 2024
News in Brief
New and updated MDCG guidance
November 8, 2024
News in Brief
MDCG 2021-4 has been updated with revision 1
October 28, 2024
Important Notice
mdi Europa: Trusted partner in the regulanet® network
October 12, 2024
Important Notice
Efficient support for medical device manufacturers: mdi Europa and the EUDAMED database
September 22, 2024
News in Brief
First global open-access information database on medical devices
August 28, 2024
News in Brief
News and publications from the European Commission
August 12, 2024
Important Notice
Draft manufacturer self-declaration and notified body confirmation letter for Regulation (EU) 2024/1860 available
August 9, 2024
News in Brief
European Commission guidance publication update
July 12, 2024
Important Notice
Amending Regulation (EU) 2024/1860 published in the OJEU
July 10, 2024
News in Brief
Update of MDCG 2022-4
June 10, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed takes last hurdle
May 31, 2024
News in Brief
European Commission publication update
May 3, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed about to be finally adopted
April 26, 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
Important Notice
Extension of IVDR transition periods and early launch of Eudamed in the pipeline
February 7, 2024
News in Brief
Update to MDCG 2021-27 on importer and distributor roles
January 12, 2024
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