Tag: Legacy Devices

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