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
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
Important Notice
AI Act published in OJEU
July 12, 2024
News in Brief
BSI first notified body to officially publish lead times under EU Medical Devices Regulations
June 14, 2024
Important Notice
European Parliament initiative for MDR improvement
June 12, 2024
News in Brief
Free scientific advice for high-risk devices
April 29, 2024
Brexit
,
News in Brief
UK-approved body capacity increases but not for IVDs
April 28, 2024
News in Brief
Could the AI Act result in the limited availability of medical technologies?
April 21, 2024
News in Brief
Request for scientific opinion on brain stimulators without a medical purpose
April 16, 2024
News in Brief
EU Artificial Intelligence Act final text agreed to by Parliament Committees
April 14, 2024
News in Brief
Availability swissdamed and new negotiations between the EU and Switzerland
April 5, 2024
Important Notice
European harmonised standards to be without charge
March 17, 2024
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
1
2
3
4
Next Page