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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
Search results
News in Brief
Team-NB position papers on MDR and IVDR technical documentation
June 7, 2023
News in Brief
EU notified body technical documentation reviews
November 17, 2022
Important Notice
,
MDR
mdi Europa experience on MDR technical documentation reviews
January 14, 2021
News in Brief
Technical Documentation format under the MDR and IVDR
December 1, 2019
CE Marking
,
MDR
Technical Documentation Requirements under the MDR – a Case Study
January 14, 2019
Technical File Compilation
August 2, 2023
Important Notice
MDCG 2025-10 — Guidance on post-market surveillance – manufacturers should review PMS documents
January 2, 2026
Important Notice
EU MDR & IVDR reform: what manufacturers need to know
December 16, 2025
News in Brief
Draft standard on clinical evaluation published
December 3, 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
New CECP Scientific Opinion Published
July 10, 2025
News in Brief
News from Team-NB
May 4, 2025
News in Brief
Team NB has been updated its Code of Conduct
November 1, 2024
News in Brief
Practical PMCF strategies and plans
October 28, 2024
Important Notice
When is a medical device impacted by the AI Act?
August 6, 2024
News in Brief
BSI first notified body to officially publish lead times under EU Medical Devices Regulations
June 14, 2024
News in Brief
Manufacturers must act now to satisfy IVDR
December 4, 2023
FAQ Section mdi Europa
August 2, 2023
EU Authorized Representative vs. Distributor
August 2, 2023
IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
August 2, 2023
MDR – Medical Devices Regulation (EU) 2017/745
August 2, 2023
OEM – Private Labeling
August 2, 2023
Library
,
Supportive Information
Supportive Information Section mdi Europa
August 1, 2023
About mdi Europa
July 19, 2023
Partners & Associates
July 17, 2023
News in Brief
News on guidance documents
March 3, 2023
MDR
,
News in Brief
elFU rules under the EU‘s MDR
January 26, 2022
IVDR
,
MDR
,
News in Brief
MDCG guidance document on distributors and importers published
December 12, 2021
Important Notice
,
MDR
New European Commission guidance document on MDR medical device classification
October 11, 2021
COVID-19
,
News in Brief
The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
August 5, 2021
Important Notice
,
IVDR
IVD or not IVD? That is the question…
April 15, 2021
COVID-19
Defined performance criteria for rapid SARS-CoV-2 antigen tests
November 5, 2020
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