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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
Library
Overview
Download Section
Supportive Information
Link Section
FAQ Section
News
Contact
About Us
Contact Persons
Contact Details
Reviews
Partners & Associates
Category:
IVDR
CE Marking
,
IVDR
,
News in Brief
The IVDR is now fully applicable – but it means not the end of the world
June 8, 2023
IVDR
,
MDR
,
News in Brief
EU guidance on authorised representatives
January 11, 2023
Important Notice
,
IVDR
,
MDR
Updated Blue Guide and MDR and IVDR harmonized standards
July 14, 2022
Important Notice
,
IVDR
,
MDR
New MDCG guidance documents under the MDR and IVDR
June 7, 2022
Important Notice
,
IVDR
MDCG publishes guidance on significant changes for legacy products under the IVDR
May 11, 2022
Important Notice
,
IVDR
,
MDR
EUDAMED update on timelines
April 10, 2022
Important Notice
,
IVDR
IVD medical devices after the IVDR date of application
March 12, 2022
IVDR
,
News in Brief
New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices
March 4, 2022
IVDR
,
News in Brief
EN ISO 13485 and symbols standards harmonised under the EU’s IVDR
February 27, 2022
Important Notice
,
IVDR
IVDR clinical evidence
February 3, 2022
Important Notice
,
IVDR
European Commission proposal for progressive roll-out of the IVDR adopted
January 5, 2022
IVDR
,
MDR
,
News in Brief
MDCG guidance document on distributors and importers published
December 12, 2021
Important Notice
,
IVDR
,
MDR
European Commission EUDAMED website expanded
December 6, 2021
IVDR
,
MDR
,
News in Brief
IEC about to publish new standard on cybersecurity
November 10, 2021
Important Notice
,
IVDR
Extended IVDR transition period for certain IVD medical devices
October 25, 2021
IVDR
,
MDR
,
News in Brief
,
Partners
Free intended use generator – an important tool under the MDR and IVDR
October 15, 2021
Important Notice
,
IVDR
,
MDR
EUDAMED UDI/Devices and NBs/Certificates modules now live
October 6, 2021
IVDR
,
MDR
,
News in Brief
MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services
October 4, 2021
IVDR
,
MDR
,
News in Brief
New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
July 4, 2021
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
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
IVDR
,
MDR
,
News in Brief
Voluntary registration with EUDAMED database – industry fears duplicate registrations
January 23, 2021
IVDR
,
News in Brief
EU IVD medical devices sector destined for crisis?
November 6, 2020
IVDR
,
MDR
,
News in Brief
New website on actor registration in EUDAMED 3 available
October 29, 2020
IVDR
,
MDR
,
News in Brief
Practical advice for setting up an MDR and IVDR compliant PMS Plan
October 22, 2020
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