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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
Tag:
European Commission
IVDR
,
MDR
,
News in Brief
EU clearance for MDR and IVDR harmonised standards
May 28, 2021
IVDR
,
MDR
,
News in Brief
EU – Switzerland MRA expired
May 27, 2021
Important Notice
,
IVDR
,
MDR
New guidance documents published by the European Commission
May 2, 2021
MDR
,
News in Brief
Commission to put forward another European standards request
August 24, 2020
News in Brief
Relocation of the European Commission website on medical devices
June 30, 2020
MDR
,
News in Brief
European Commission’s device standardisation request rejected
June 23, 2020
MDR
,
News in Brief
Updated timetable for Eudamed
June 7, 2020
COVID-19
,
Important Notice
,
News in Brief
Surgical and FFP masks in the COVID-19 crisis
May 8, 2020
Important Notice
,
MDR
MDR Postponed by One Year!
April 28, 2020
COVID-19
,
Important Notice
European Commission gives details of how to prevent COVID-19 test failures
April 23, 2020
Important Notice
,
MDR
MDR Postponement – Handle with Care!
April 21, 2020
COVID-19
,
Important Notice
Guidance on MD and PPE in times of COVID-19 and local provisions
April 9, 2020
Important Notice
,
MDR
Latest MDCG Preparedness Plan and MDR Delay
March 26, 2020
Important Notice
,
News in Brief
European Commission Recommendation on Regulatory Exemptions for COVID-19 Products
March 23, 2020
Important Notice
,
News in Brief
News on EUDAMED
November 7, 2019
Important Notice
,
News in Brief
European Commission Website on Regulations MDR / IVDR Restructured
August 21, 2019
News in Brief
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
August 15, 2019
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