Skip to content
Home
CE Marking
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
EU Importer
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
Home
CE Marking
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
EU Importer
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
NEWS
Important Notice
New EU Regulation on notified body conformity assessments published
May 12, 2026
News in Brief
New Team-NB position paper: Clinical evaluation under MDR article 61(10)
May 10, 2026
News in Brief
Provisional agreement on EU Digital Omnibus on AI
May 9, 2026
Important Notice
EUDAMED training 2026 – key opportunity for all medical device stakeholders
May 8, 2026
News in Brief
Switzerland–EU MRA: Momentum returns, but a long way to go
May 3, 2026
News in Brief
Update Alert from the European Commission – borderline products, EMDN codes, MIR status and clinical investigations/ performance studies
May 2, 2026
Important Notice
MDCG 2021-24 Rev.1, updated classification guidance published
April 29, 2026
News in Brief
EU AI Act: Parliament votes to delay high-risk rules
April 17, 2026
News in Brief
New harmonised standards for sterilizers and hearing aids listed under the MDR
April 12, 2026
News in Brief
New CECP opinion published: Expert panel backs extended indication for cardiac pacing lead
April 10, 2026
News in Brief
Navigating supply interruptions: European Commission publishes revised Q&A on article 10a obligations
April 3, 2026
News in Brief
Recording now available: Commission high level conference on MDR/IVDR revision
April 2, 2026
Important Notice
Updated MIR form v7.3.1: Mandatory from 1 May 2026
March 31, 2026
Important Notice
European Commission adopts two MDR amendments easing conformity assessment obligations
March 23, 2026
News in Brief
Action required: IVDR class C legacy device deadlines are approaching
March 15, 2026
News in Brief
Team-NB sets out expectations for combinatorial IVD medical device claims
March 11, 2026
News in Brief
EU regulatory overhaul sparks debate
March 8, 2026
Brexit
MHRA opens consultation on the future of CE marking in Great Britain
March 2, 2026
News in Brief
European Commission hosts conference on medical devices in March
February 5, 2026
News in Brief
New set of harmonized standards published
January 30, 2026
1
2
3
…
17
Next Page
