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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
Author:
Oliver Giesemann
COVID-19
,
News in Brief
Guidance document on the impact of genetic variants on SARS-COV-2
May 29, 2021
IVDR
,
MDR
,
News in Brief
Guidance on legacy devices regarding Eudamed
May 3, 2021
Important Notice
,
IVDR
,
MDR
New guidance documents published by the European Commission
May 2, 2021
Important Notice
,
IVDR
,
MDR
Updated EUDAMED implementation dates
April 1, 2021
Important Notice
,
IVDR
,
MDR
MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality
March 15, 2021
COVID-19
,
News in Brief
Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons
March 8, 2021
COVID-19
,
News in Brief
European Commission publishes Q&A guidance on COVID-19 tests
March 1, 2021
IVDR
,
MDR
,
News in Brief
Voluntary registration with EUDAMED database – industry fears duplicate registrations
January 23, 2021
COVID-19
Defined performance criteria for rapid SARS-CoV-2 antigen tests
November 5, 2020
IVDR
,
MDR
,
News in Brief
New website on actor registration in EUDAMED 3 available
October 29, 2020
IVDR
,
MDR
,
News in Brief
Get ready for the economic operator registration in EUDAMED
October 9, 2020
IVDR
,
MDR
,
News in Brief
EUDAMED economic operator registration module available as of December 2020
September 16, 2020
IVDR
,
MDR
,
News in Brief
Updated Q&A document on MDR and IVDR UDI requirements from the European Commission
August 12, 2020
COVID-19
,
News in Brief
Update from the European Commission for protective equipment in the COVID-19 crisis
July 20, 2020
COVID-19
,
News in Brief
COVID-19 In Vitro Diagnostic Devices and Test Methods Database available
July 2, 2020
News in Brief
Relocation of the European Commission website on medical devices
June 30, 2020
COVID-19
,
News in Brief
European Commission guidance on surgical masks
June 29, 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
COVID-19
,
Important Notice
European Commission gives details of how to prevent COVID-19 test failures
April 23, 2020
COVID-19
,
Important Notice
Guidance on MD and PPE in times of COVID-19 and local provisions
April 9, 2020
Important Notice
,
News in Brief
European Commission Recommendation on Regulatory Exemptions for COVID-19 Products
March 23, 2020
Important Notice
MDCG guidance documents on MDR codes and sampling of MDR and IVDR devices published
January 6, 2020
Important Notice
,
MDR
Second MDR corrigendum published
December 18, 2019
News in Brief
Early access to Single Registration Numbers (SRN)
December 16, 2019
News in Brief
New MDR and IVDR checklists for PMS and Declaration of Conformity
December 7, 2019
News in Brief
News on symbols to be used under the MDR and IVDR
December 5, 2019
Important Notice
,
News in Brief
News on EUDAMED
November 7, 2019
News in Brief
Guidance on Qualification and Classification of Software under the MDR and IVDR Published
October 28, 2019
Important Notice
MDCG Guidance on MDD Certificates and SSCP under the MDR
October 15, 2019
News in Brief
News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices
September 4, 2019
Important Notice
,
News in Brief
European Commission Website on Regulations MDR / IVDR Restructured
August 21, 2019
News in Brief
New Checklist for Clinical Evaluations Available
August 19, 2019
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