Category: Important Notice

Breaking news on CE Marking, MDR, IVDR, Regulatory Affairs, Guidance Documents, MDCG, EUDAMED, European Commission, Brexit etc.

Important Notice

Different options for IVD medical devices until Eudamed becomes fully operational

September 2, 2022
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, MDR

New guidance on borderline products between drugs and medical devices under the MDR

June 1, 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

Ukraine tries to maintain business as usual

April 6, 2022
Important Notice, IVDR

IVD medical devices after the IVDR date of application

March 12, 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
Important Notice, IVDR, MDR

European Commission EUDAMED website expanded

December 6, 2021
Important Notice, IVDR

Extended IVDR transition period for certain IVD medical devices

October 25, 2021
Important Notice, MDR

New European Commission guidance document on MDR medical device classification

October 11, 2021
Important Notice, IVDR, MDR

EUDAMED UDI/Devices and NBs/Certificates modules now live

October 6, 2021
Important Notice

Insufficient sterilization of medical devices by Steril Milano S.r.l

June 28, 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
Important Notice, MDR

mdi Europa experience on MDR technical documentation reviews

January 14, 2021
Important Notice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
Important Notice

EU guidance on Notified Body clinical evaluation assessment reports

July 24, 2020
Important Notice, MDR

Clinical evaluation and equivalence – using literature under the MDR

June 5, 2020
Important Notice

Medical Device Distribution in France

May 18, 2020
COVID-19, Important Notice, News in Brief

Surgical and FFP masks in the COVID-19 crisis

May 8, 2020
Important Notice, MDR

Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

April 29, 2020
Important Notice, MDR

MDR Postponed by One Year!

April 28, 2020
COVID-19, Important Notice

European Commission gives details of how to prevent COVID-19 test failures

April 23, 2020
Important Notice, MDR

MDR Postponement – Handle with Care!

April 21, 2020
Important Notice, IVDR, MDR

MDR and IVDR guidance updates

April 9, 2020
COVID-19, Important Notice

Guidance on MD and PPE in times of COVID-19 and local provisions

April 9, 2020
Important Notice, MDR

Latest MDCG Preparedness Plan and MDR Delay

March 26, 2020