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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
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
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
Important Notice
EU medical device industry faces further delays related to EUDAMED
November 7, 2023
News in Brief
Harmonization of MDR and IVDR standards still slow
August 14, 2023
COVID-19
,
News in Brief
COVID-19 tests and their risk classification
August 2, 2023
Important Notice
EU AI Act approved by Parliament
July 3, 2023
News in Brief
Spain brings in additional national requirements
May 27, 2023
Important Notice
Registering a legacy device in Eudamed is a good step
May 12, 2023
News in Brief
UDI helpdesk website published
April 13, 2023
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