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CE Marking Medical Devices
CE Marking
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IVDR
Certificates of Free Sale
OEM – Private Labeling
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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
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
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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