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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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Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
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Contact Details
Reviews
Partners & Associates
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
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
Sponsors are now invited to apply for the EU’s pilot programme aimed at expediting clinical investigations and performance studies
March 22, 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
News in Brief
Non-EU medical technology companies could encounter lawsuits due to revised product liability directive
March 6, 2025
Brexit
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Important Notice
UK MHRA advises to begin implementing PMS guidance prior to June regulation
February 23, 2025
Important Notice
EC REP to EU REP: A new symbol for European Authorized Representatives
February 14, 2025
News in Brief
Industry and policymakers push for medical technology regulatory reforms in the EU
February 12, 2025
Important Notice
Guidance on SARS-CoV-2 test classification and news on EMDN coding
February 6, 2025
News in Brief
Medtech companies facing risk of non-compliance as EU AI deadlines approach
February 3, 2025
News in Brief
Swissmedic launches a initiative on post-market surveillance
February 1, 2025
News in Brief
Switzerland moves closer to regulatory progress in medical technology
February 1, 2025
Important Notice
mdi Europa expands services
January 22, 2025
News in Brief
The European Union simplifies the management of multinational combination product trials
January 18, 2025
Important Notice
Meet mdi Europa at Arab Health 2025
January 15, 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
Brexit
New post-market surveillance requirements in Great Britain: Key changes for medical device companies
January 7, 2025
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