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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
NEWS
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
Team NB has been updated its Code of Conduct
November 1, 2024
News in Brief
Practical PMCF strategies and plans
October 28, 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
News in Brief
EU on proposed regulations for seven high-risk IVD test categories
October 2, 2024
News in Brief
TEAM-NB position paper on IVDR transfer agreement for surveillance
September 26, 2024
Important Notice
MDR extended transition period and notified body agreement
September 26, 2024
Important Notice
Efficient support for medical device manufacturers: mdi Europa and the EUDAMED database
September 22, 2024
News in Brief
EU launches call for regulatory medical technology innovation sandbox
September 12, 2024
Important Notice
The medical technology sector faces significant changes due to the EU’s upcoming PFAS restriction
September 9, 2024
News in Brief
First global open-access information database on medical devices
August 28, 2024
News in Brief
The EU’s standardisation guidance MDCG 2021-5 has been updated
August 14, 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
Important Notice
When is a medical device impacted by the AI Act?
August 6, 2024
News in Brief
EU guidelines for justifying phthalates in medical devices updated
July 26, 2024
Important Notice
AI Act published in OJEU
July 12, 2024
News in Brief
European Commission guidance publication update
July 12, 2024
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