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
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
MDR
,
News in Brief
MDR harmonised standards update
February 27, 2022
COVID-19
,
News in Brief
New guidance for third-country manufacturers of COVID-19 IVD tests
February 6, 2022
Important Notice
,
IVDR
IVDR clinical evidence
February 3, 2022
MDR
,
News in Brief
elFU rules under the EU‘s MDR
January 26, 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
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
Previous Page
1
…
6
7
8
9
10
…
14
Next Page
