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CE Marking Medical Devices
CE Marking
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Certificates of Free Sale
OEM – Private Labeling
Technical File Compilation
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CE Consulting Electrical Equipment – EMC / LVD
CE Consulting Environmental Requirements – WEEE / RoHS
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European Authorized Representation for Manufacturers of Medical Devices
EU Authorized Representative Responsibilities
EU Authorized Representative vs. Distributor
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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
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
Search results
COVID-19
,
Important Notice
Guidance on MD and PPE in times of COVID-19 and local provisions
April 9, 2020
Important Notice
New guidance documents for EMDN and cybersecurity
February 13, 2020
Important Notice
MDCG guidance documents on MDR codes and sampling of MDR and IVDR devices published
January 6, 2020
Important Notice
Guidance document for class I device manufacturers
December 23, 2019
News in Brief
Guidance on Qualification and Classification of Software under the MDR and IVDR Published
October 28, 2019
Important Notice
MDCG Guidance on MDD Certificates and SSCP under the MDR
October 15, 2019
Brexit
New Guidance for the UK Responsible Person Published
September 26, 2019
CE Consulting
,
EU Authorized Representative
A True Story about Trust and Guidance
August 18, 2019
News in Brief
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
August 15, 2019
Important Notice
,
News in Brief
Guidance on Person Responsible for Regulatory Compliance
June 23, 2019
News in Brief
Guidance on Implant Cards
June 23, 2019
News in Brief
EU Guidance on Quality Rules for Drug-Device Combinations
June 4, 2019
News in Brief
Updated Clinical Evaluation Guidance on Comparability
April 8, 2019
News in Brief
Guidance on Article 54(2)b of Regulation (EU) 2017/745 on medical devices (MDR)
March 22, 2019
Important Notice
European harmonised standards to be without charge
March 17, 2024
Download Section
,
Library
Complete Download Section mdi Europa
March 16, 2024
Important Notice
Language requirements overview for the Union market
February 14, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed in the pipeline
February 7, 2024
Important Notice
EU’s first reference laboratories for high-risk Class D IVDs
January 14, 2024
News in Brief
Update to MDCG 2021-27 on importer and distributor roles
January 12, 2024
News in Brief
European Commission publications update on clinical investigations and annex XVI products
January 11, 2024
News in Brief
Manufacturers must act now to satisfy IVDR
December 4, 2023
News in Brief
EU rules for device software working with hardware
November 29, 2023
News in Brief
European Commission publications update
November 15, 2023
News in Brief
Is a centralised governance agency for medical devices feasible?
November 1, 2023
Important Notice
A closer look at MDCG 2023-3 on vigilance
August 11, 2023
News in Brief
Cybersecurity expertise shortage in EU
August 7, 2023
FAQ Section mdi Europa
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
Library
,
Link Section
Complete Link Section mdi Europa
August 1, 2023
Library
,
Supportive Information
Supportive Information Section mdi Europa
August 1, 2023
About mdi Europa
July 19, 2023
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