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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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News
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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
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
IVDR
,
MDR
,
News in Brief
MDCG guidance document on distributors and importers published
December 12, 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
MDR
,
News in Brief
New guidance on legacy devices published
November 12, 2021
IVDR
,
MDR
,
News in Brief
IEC about to publish new standard on cybersecurity
November 10, 2021
Important Notice
,
IVDR
Extended IVDR transition period for certain IVD medical devices
October 25, 2021
IVDR
,
MDR
,
News in Brief
,
Partners
Free intended use generator – an important tool under the MDR and IVDR
October 15, 2021
Important Notice
,
MDR
New European Commission guidance document on MDR medical device classification
October 11, 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
COVID-19
,
News in Brief
The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
August 5, 2021
MDR
,
News in Brief
Team-NB publishes position paper on the applicability of MDR implant card requirements
August 1, 2021
News in Brief
bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning
July 12, 2021
News in Brief
The IVDR and performance evaluation studies
July 8, 2021
IVDR
,
MDR
,
News in Brief
New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
July 4, 2021
Important Notice
Insufficient sterilization of medical devices by Steril Milano S.r.l
June 28, 2021
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