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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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Supportive Information
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FAQ Section
News
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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
Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN
June 15, 2021
IVDR
,
MDR
,
News in Brief
EU UDI helpdesk available
June 10, 2021
IVDR
,
MDR
,
News in Brief
Standard ISO 20417:2021 for the MDR and IVDR published
June 3, 2021
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
EU clearance for MDR and IVDR harmonised standards
May 28, 2021
IVDR
,
MDR
,
News in Brief
EU – Switzerland MRA expired
May 27, 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
IVD or not IVD? That is the question…
April 15, 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
Brexit
,
News in Brief
Additional MHRA guidance for medical device companies
January 17, 2021
Important Notice
,
MDR
mdi Europa experience on MDR technical documentation reviews
January 14, 2021
News in Brief
BfArM informs about damages to hip implants
December 13, 2020
Important Notice
Key guidance document on the classification of IVDs under the IVDR
December 1, 2020
IVDR
,
News in Brief
EU IVD medical devices sector destined for crisis?
November 6, 2020
Important Notice
,
MDR
Sufficient clinical evidence under the MDR for class I legacy devices
November 3, 2020
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