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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
UK & Swiss Services
UK Responsible Person (UKRP)
Swiss Authorized Representative
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Overview
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Supportive Information
Link Section
FAQ Section
News
Contact
About Us
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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
NEWS
IVDR
,
MDR
,
News in Brief
New website on actor registration in EUDAMED 3 available
October 29, 2020
Brexit
,
News in Brief
Latest UK MHRA updates on Northern Ireland and EU device regulation guidance
October 26, 2020
IVDR
,
MDR
,
News in Brief
Practical advice for setting up an MDR and IVDR compliant PMS Plan
October 22, 2020
IVDR
,
MDR
,
News in Brief
Get ready for the economic operator registration in EUDAMED
October 9, 2020
Brexit
,
News in Brief
New UKCA mark after Brexit
September 17, 2020
IVDR
,
MDR
,
News in Brief
EUDAMED economic operator registration module available as of December 2020
September 16, 2020
News in Brief
Guidance checklist for manufacturers of reusable and resterilizable medical devices
September 3, 2020
MDR
,
News in Brief
Commission to put forward another European standards request
August 24, 2020
IVDR
,
MDR
,
News in Brief
New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits
August 21, 2020
IVDR
,
MDR
,
News in Brief
Updated Q&A document on MDR and IVDR UDI requirements from the European Commission
August 12, 2020
MDR
,
News in Brief
ISO TR 20416 and PMS under the MDR
August 1, 2020
Important Notice
EU guidance on Notified Body clinical evaluation assessment reports
July 24, 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
European Commission’s device standardisation request rejected
June 23, 2020
MDR
,
News in Brief
Updated timetable for Eudamed
June 7, 2020
Important Notice
,
MDR
Clinical evaluation and equivalence – using literature under the MDR
June 5, 2020
IVDR
,
MDR
,
News in Brief
New MDR and IVDR guidance documents published by MDCG and MedTech Europe
June 1, 2020
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