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CE Marking Medical Devices
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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:
MDR
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
Potential applicability of Regulation (EU) 2023/1115
March 12, 2024
News in Brief
Revised product liability directive
March 9, 2024
Important Notice
Language requirements overview for the Union market
February 14, 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
AI significant in October regulatory discussions
December 1, 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
Important Notice
EU medical device industry faces further delays related to EUDAMED
November 7, 2023
News in Brief
Is a centralised governance agency for medical devices feasible?
November 1, 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
News in Brief
Harmonization of MDR and IVDR standards still slow
August 14, 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
Library
,
Supportive Information
Supportive Information Section mdi Europa
August 1, 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
Swiss Federal Council to mirror extended transition timelines for MDR legacy devices
June 2, 2023
News in Brief
Spain brings in additional national requirements
May 27, 2023
Important Notice
Registering a legacy device in Eudamed is a good step
May 12, 2023
News in Brief
UDI helpdesk website published
April 13, 2023
Important Notice
Q&A document published on the extended transition period for medical devices under the MDR
April 11, 2023
Important Notice
MDR extended transition timelines and removal of MDR and IVDR sell-off period adopted
March 20, 2023
News in Brief
News on guidance documents
March 3, 2023
Important Notice
European Commission proposal text accepted
March 1, 2023
News in Brief
Guidance document on in-house devices
February 15, 2023
Important Notice
European Commission proposal for extended transition timelines published
January 12, 2023
IVDR
,
MDR
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News in Brief
EU guidance on authorised representatives
January 11, 2023
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