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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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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
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
Important Notice
Medical Device Distribution in France
May 18, 2020
COVID-19
,
Important Notice
,
News in Brief
Surgical and FFP masks in the COVID-19 crisis
May 8, 2020
Important Notice
,
MDR
Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published
April 29, 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
Important Notice
,
IVDR
,
MDR
MDR and IVDR guidance updates
April 9, 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
News in Brief
Usability and the MDR
March 12, 2020
News in Brief
Update on Notified Bodies
March 4, 2020
Important Notice
New guidance documents for EMDN and cybersecurity
February 13, 2020
Brexit
,
News in Brief
Brexit and the regulatory situation for the medtech industry
February 3, 2020
News in Brief
Latest version of ISO 14971 on risk management and the MDR and IVDR
January 8, 2020
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