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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
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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
Month:
October 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
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