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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
UK & Swiss Services
UK Responsible Person (UKRP)
Swiss Authorized Representative
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Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
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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
UK & Swiss Services
UK Responsible Person (UKRP)
Swiss Authorized Representative
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
NEWS
Brexit
,
News in Brief
UK MHRA gives CE marked devices new transition deadlines
July 4, 2023
Important Notice
EU AI Act approved by Parliament
July 3, 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
Brexit
,
News in Brief
UK updated guidance will reflect EU extensions
May 15, 2023
Important Notice
Registering a legacy device in Eudamed is a good step
May 12, 2023
News in Brief
Proposed general product safety regulation is expected to entry into force shortly
May 2, 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
Brexit
UK MHRA’s new and higher charges for medical devices
March 1, 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
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