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