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CE Marking Medical Devices
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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
Search results
FAQ
Stop your Confusion about CE Marking – read our FAQ
July 17, 2023
Brexit
,
News in Brief
UK MHRA gives CE marked devices new transition deadlines
July 4, 2023
CE Marking
,
IVDR
,
News in Brief
The IVDR is now fully applicable – but it means not the end of the world
June 8, 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
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
News in Brief
Templates on hand for sponsors of IVD performance studies
February 15, 2023
News in Brief
EU notified bodies on harmonised standards regarding cybersecurity
January 6, 2023
News in Brief
EU notified body technical documentation reviews
November 17, 2022
News in Brief
Cybersecurity in the EU
November 8, 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
Important Notice
Different options for IVD medical devices until Eudamed becomes fully operational
September 2, 2022
Important Notice
,
IVDR
,
MDR
Updated Blue Guide and MDR and IVDR harmonized standards
July 14, 2022
News in Brief
EU has to deal with discords between AI and medical device rules
July 1, 2022
Important Notice
,
IVDR
,
MDR
EUDAMED update on timelines
April 10, 2022
News in Brief
New cybersecurity standard
April 2, 2022
Important Notice
,
IVDR
IVD medical devices after the IVDR date of application
March 12, 2022
Important Notice
,
IVDR
IVDR clinical evidence
February 3, 2022
Important Notice
,
IVDR
European Commission proposal for progressive roll-out of the IVDR adopted
January 5, 2022
News in Brief
New artificial intelligence regulations could lead to unnecessary burdens
December 29, 2021
MDR
,
News in Brief
bsi white paper on clinical evaluations
December 15, 2021
Important Notice
,
IVDR
,
MDR
European Commission EUDAMED website expanded
December 6, 2021
Brexit
,
News in Brief
Consultation on amending UK medical devices regulations
December 2, 2021
News in Brief
The MDR is now fully applicable – but it means not the end of the world
November 15, 2021
Important Notice
,
IVDR
Extended IVDR transition period for certain IVD medical devices
October 25, 2021
COVID-19
SARS-CoV-2 IVD tests and the IVDR
October 7, 2021
Important Notice
,
IVDR
,
MDR
EUDAMED UDI/Devices and NBs/Certificates modules now live
October 6, 2021
IVDR
,
MDR
,
News in Brief
MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services
October 4, 2021
MDR
,
News in Brief
bsi article on clinical evaluation requirements under the MDR
August 8, 2021
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