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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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News
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About Us
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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
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
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
News in Brief
Guidance updates from the European Commission and TEAM-NB
January 7, 2025
News in Brief
Medical technology industry calls for urgent EU action
December 18, 2024
News in Brief
Additional updates from the European Commission
December 9, 2024
News in Brief
MHRA announces a new phase for UK medical device regulation
December 6, 2024
Important Notice
MDCG Q&A document on vigilance updated
December 2, 2024
News in Brief
TEAM NB published questionnaire on AI in medical devices
December 1, 2024
Important Notice
Q&A document on the gradual rollout of EUDAMED available
November 30, 2024
News in Brief
Council of the European Union proposes key elements for MDR/ IVDR reform
November 29, 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
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