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CE Marking Medical Devices
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IVDR
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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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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
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
Author:
Michael Sander
News in Brief
EU Data Act causes difficulties for medical device manufacturers
March 14, 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
Important Notice
EU’s first reference laboratories for high-risk Class D IVDs
January 14, 2024
News in Brief
Manufacturers must act now to satisfy IVDR
December 4, 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
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
The European Commission’s AI Act now in final negotiation phase
August 24, 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
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
Proposed general product safety regulation is expected to entry into force shortly
May 2, 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
Important Notice
European Commission proposal text accepted
March 1, 2023
Important Notice
EU guidance on Periodic Safety Update Reports
February 27, 2023
News in Brief
Templates on hand for sponsors of IVD performance studies
February 15, 2023
News in Brief
New EU approach on cancer screening
February 15, 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
,
News in Brief
EU guidance on authorised representatives
January 11, 2023
Important Notice
European Commission proposed MDR deadlines extension for legacy devices
December 14, 2022
News in Brief
EU notified body technical documentation reviews
November 17, 2022
News in Brief
News on useful publications: MDCG borderline manual and bsi white paper on performance evaluations
October 13, 2022
News in Brief
Criticism on the EU’s 19-Point Regulatory Action Plan
October 11, 2022
Important Notice
Danger of cybersecurity attacks?
September 26, 2022
Important Notice
EU’s Implementing Regulation on Common Specifications for class D IVDs
September 6, 2022
News in Brief
EU has to deal with discords between AI and medical device rules
July 1, 2022
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