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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
Tag:
Guidance Documents
Download Section
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Library
Complete Download Section mdi Europa
October 11, 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
TEAM NB issued revision 2 of IVDR best practice document
September 10, 2025
News in Brief
European Commission publishes template for summary of training data
August 7, 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
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
News in Brief
News from Team-NB
May 4, 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
Guidance on SARS-CoV-2 test classification and news on EMDN coding
February 6, 2025
News in Brief
Implementing regulations on eIFU, well-established technologies and orphan/ pediatric devices in sight
January 11, 2025
News in Brief
Guidance updates from the European Commission and TEAM-NB
January 7, 2025
News in Brief
Additional updates from the European Commission
December 9, 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
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
News in Brief
MDCG 2021-4 has been updated with revision 1
October 28, 2024
News in Brief
First global open-access information database on medical devices
August 28, 2024
News in Brief
The EU’s standardisation guidance MDCG 2021-5 has been updated
August 14, 2024
Important Notice
Draft manufacturer self-declaration and notified body confirmation letter for Regulation (EU) 2024/1860 available
August 9, 2024
News in Brief
EU guidelines for justifying phthalates in medical devices updated
July 26, 2024
News in Brief
European Commission guidance publication update
July 12, 2024
News in Brief
European Commission publication update
May 3, 2024
News in Brief
MDCG published guidance on EMDN code updates and clinical investigation plans
March 13, 2024
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