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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
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
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
News in Brief
News on symbols to be used under the MDR and IVDR
December 5, 2019
News in Brief
Technical Documentation format under the MDR and IVDR
December 1, 2019
Important Notice
,
News in Brief
News on EUDAMED
November 7, 2019
News in Brief
DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR
November 6, 2019
Brexit
News on Brexit
October 29, 2019
News in Brief
Guidance on Qualification and Classification of Software under the MDR and IVDR Published
October 28, 2019
Important Notice
,
IVDR
Performance Evaluation for IVD Medical Devices
October 28, 2019
Important Notice
MDCG Guidance on MDD Certificates and SSCP under the MDR
October 15, 2019
News in Brief
New Notified Bodies Designated under the MDR and IVDR
October 15, 2019
Brexit
New Guidance for the UK Responsible Person Published
September 26, 2019
Brexit
All About Brexit – But We’re Not Clairvoyant
September 16, 2019
News in Brief
CE Marking Made Easy, Like a Day at the Beach
September 16, 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
Brexit
United Kingdom (UK) to Request ‘UK Responsible Person’
August 19, 2019
News in Brief
New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
August 15, 2019
News in Brief
BfArM Informs about Insufficient Labeling of Speaking Valves
July 31, 2019
News in Brief
Recommendation of BfArM regarding Breathing Hoses in Anesthesia
July 22, 2019
News in Brief
Most Important Changes – Regulation (EU) 2017/745 on Medical Devices (MDR)
July 17, 2019
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