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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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UK Responsible Person (UKRP)
Swiss Authorized Representative
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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
Author:
Oliver Giesemann
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
News in Brief
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
August 15, 2019
Important Notice
,
News in Brief
Guidance on Person Responsible for Regulatory Compliance
June 23, 2019
News in Brief
Guidance on Implant Cards
June 23, 2019
Important Notice
,
News in Brief
Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics
June 14, 2019
News in Brief
EU Guidance on Quality Rules for Drug-Device Combinations
June 4, 2019
News in Brief
Updated Clinical Evaluation Guidance on Comparability
April 8, 2019
Important Notice
,
News in Brief
Device Registration and Legacy Devices
April 2, 2019
News in Brief
Guidance on Article 54(2)b of Regulation (EU) 2017/745 on medical devices (MDR)
March 22, 2019
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