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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
Tag:
Legacy Devices
News in Brief
TEAM-NB position paper on IVDR transfer agreement for surveillance
September 26, 2024
Important Notice
MDR extended transition period and notified body agreement
September 26, 2024
Important Notice
Draft manufacturer self-declaration and notified body confirmation letter for Regulation (EU) 2024/1860 available
August 9, 2024
Important Notice
Amending Regulation (EU) 2024/1860 published in the OJEU
July 10, 2024
News in Brief
Update of MDCG 2022-4
June 10, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed takes last hurdle
May 31, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed about to be finally adopted
April 26, 2024
Important Notice
Extension of IVDR transition periods and early launch of Eudamed in the pipeline
February 7, 2024
Important Notice
Advice on how to satisfy EU requirements for MDR legacy devices
October 6, 2023
Important Notice
Update on Regulation (EU) 2023/607 – extended MDR transition period
September 12, 2023
News in Brief
MDCG 2020-3 updated
June 5, 2023
News in Brief
Swiss Federal Council to mirror extended transition timelines for MDR legacy devices
June 2, 2023
Important Notice
Registering a legacy device in Eudamed is a good step
May 12, 2023
Important Notice
Q&A document published on the extended transition period for medical devices under the MDR
April 11, 2023
Important Notice
MDR extended transition timelines and removal of MDR and IVDR sell-off period adopted
March 20, 2023
Important Notice
European Commission proposal text accepted
March 1, 2023
Important Notice
European Commission proposal for extended transition timelines published
January 12, 2023
Important Notice
European Commission proposed MDR deadlines extension for legacy devices
December 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
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
MDR
,
News in Brief
New guidance on legacy devices published
November 12, 2021
IVDR
,
MDR
,
News in Brief
Guidance on legacy devices regarding Eudamed
May 3, 2021
Important Notice
MDCG Guidance on MDD Certificates and SSCP under the MDR
October 15, 2019
Important Notice
,
News in Brief
Device Registration and Legacy Devices
April 2, 2019
