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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
Tag:
IVDR
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Complete Download Section mdi Europa
January 17, 2026
Important Notice
MDCG 2025-10 — Guidance on post-market surveillance – manufacturers should review PMS documents
January 2, 2026
News in Brief
MDCG 2025-9 — Guidance on breakthrough devices (BtX)
December 23, 2025
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
Important Notice
EU MDR & IVDR reform: what manufacturers need to know
December 16, 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
Important Notice
MDCG Q&A — trend reporting
October 6, 2025
News in Brief
Manual on Borderline and Classification under the MDR and IVDR updated
October 1, 2025
News in Brief
EN IEC 61326-2-6 was updated
September 28, 2025
News in Brief
EU4Health supports orphan devices and SMEs
September 17, 2025
News in Brief
TEAM NB issued revision 2 of IVDR best practice document
September 10, 2025
Important Notice
Targeted revision: MDR & IVDR — Have your say
September 5, 2025
Important Notice
Updates for Switzerland – eIFU and device registration
August 31, 2025
News in Brief
EU pilot for all-in-one regulatory pathway for drug and diagnostic trials
July 23, 2025
Important Notice
MDCG published guidance 2025-6
July 8, 2025
Important Notice
Guidance on EU MDR/ IVDR and AI Act interplay
July 8, 2025
News in Brief
MDCG 2019-11 rev. 1 published by the European Commission
July 1, 2025
News in Brief
New Q&A Guidance: MDCG 2025-5 on IVDR Performance Studies
June 25, 2025
News in Brief
New MDCG Guidance Alert
June 25, 2025
Important Notice
More standards under MDR and IVDR harmonized
May 5, 2025
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
New and updated guidance for the MDR and IVDR
March 15, 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
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
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
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