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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
Author:
Oliver Giesemann
News in Brief
EU PPWR labeling for medical devices: More information, same limited space
September 27, 2026
News in Brief
EU packaging rules are changing: What medical device companies need to know
August 20, 2026
Important Notice
Commission publishes central overview of notified body fees
August 19, 2026
News in Brief
EMDN training material available
August 19, 2026
News in Brief
MDCG 2026-5: UDI assignments between manufacturers and distributors
August 19, 2026
Important Notice
Swissmedic issues information sheet on swissdamed registration fees
August 19, 2026
News in Brief
Updated XSD and XSL files for vigilance reporting
July 20, 2026
News in Brief
SS(C)P upload moves to manufacturers: MDCG 2026-4 sets the EUDAMED timeline
June 30, 2026
News in Brief
Swissmedic confirms swissdamed registration fees
June 3, 2026
News in Brief
EU unlocks new funding for health AI projects
May 26, 2026
News in Brief
New EUDAMED version released
May 23, 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
News in Brief
New CECP opinion published: Expert panel backs extended indication for cardiac pacing lead
April 10, 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
News in Brief
Action required: IVDR class C legacy device deadlines are approaching
March 15, 2026
News in Brief
European Commission hosts conference on medical devices in March
February 5, 2026
Important Notice
Draft implementing regulation — notified body practices
December 19, 2025
Important Notice
The EUDAMED first four modules will be mandatory to use as from 28 May 2026
December 17, 2025
News in Brief
News from the European Commission
December 9, 2025
News in Brief
Team-NB position paper — When companion-diagnostic changes require notified-body approval
November 21, 2025
News in Brief
Clinical evidence requirements under the IVDR — MedTech Europe eBook
October 8, 2025
News in Brief
EU4Health supports orphan devices and SMEs
September 17, 2025
News in Brief
New Revision: MDCG 2024-14 Rev. 1 on Master UDI-DI for Contact Lenses
September 14, 2025
News in Brief
The European Commission published MDCG 2025-7 on the use of a Master UDI-DI for certain optical devices
August 3, 2025
News in Brief
General-Purpose AI Code of Practice published
July 15, 2025
Important Notice
Electronic Instructions for Use (eIFU) for Professional Use Medical Devices
July 9, 2025
Important Notice
Guidance on EU MDR/ IVDR and AI Act interplay
July 8, 2025
Important Notice
New MIR Form 7.3.1 Now Accepted in Switzerland
June 2, 2025
News in Brief
European Medical Devices Nomenclature (EMDN) helpdesk is live!
May 31, 2025
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