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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
Tag:
Guidance Documents
Download Section
,
Library
Complete Download Section mdi Europa
March 16, 2024
News in Brief
MDCG published guidance on EMDN code updates and clinical investigation plans
March 13, 2024
News in Brief
MDCG published device specific vigilance guidance
February 8, 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
EU rules for device software working with hardware
November 29, 2023
News in Brief
European Commission publications update
November 15, 2023
News in Brief
European Commission publishes third revision of the borderline manual
October 10, 2023
Important Notice
Advice on how to satisfy EU requirements for MDR legacy devices
October 6, 2023
Important Notice
Update on Regulation (EU) 2023/607 – extended MDR transition period
September 12, 2023
Important Notice
A closer look at MDCG 2023-3 on vigilance
August 11, 2023
News in Brief
Team-NB position papers on MDR and IVDR technical documentation
June 7, 2023
News in Brief
MDCG 2020-3 updated
June 5, 2023
News in Brief
News on guidance documents
March 3, 2023
News in Brief
Templates on hand for sponsors of IVD performance studies
February 15, 2023
News in Brief
Guidance document on in-house devices
February 15, 2023
IVDR
,
MDR
,
News in Brief
EU guidance on authorised representatives
January 11, 2023
Important Notice
EU’s Implementing Regulation on Common Specifications for class D IVDs
September 6, 2022
Important Notice
Different options for IVD medical devices until Eudamed becomes fully operational
September 2, 2022
Important Notice
,
IVDR
,
MDR
New MDCG guidance documents under the MDR and IVDR
June 7, 2022
Important Notice
,
MDR
New guidance on borderline products between drugs and medical devices under the MDR
June 1, 2022
Important Notice
,
IVDR
MDCG publishes guidance on significant changes for legacy products under the IVDR
May 11, 2022
IVDR
,
News in Brief
New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices
March 4, 2022
COVID-19
,
News in Brief
New guidance for third-country manufacturers of COVID-19 IVD tests
February 6, 2022
Important Notice
,
IVDR
IVDR clinical evidence
February 3, 2022
IVDR
,
MDR
,
News in Brief
MDCG guidance document on distributors and importers published
December 12, 2021
MDR
,
News in Brief
New guidance on legacy devices published
November 12, 2021
Important Notice
,
MDR
New European Commission guidance document on MDR medical device classification
October 11, 2021
COVID-19
SARS-CoV-2 IVD tests and the IVDR
October 7, 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
News in Brief
The IVDR and performance evaluation studies
July 8, 2021
IVDR
,
MDR
,
News in Brief
New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
July 4, 2021
IVDR
,
MDR
,
News in Brief
Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN
June 15, 2021
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