News | mdi Europa

NEWS

News in Brief

Criticism on the EU’s 19-Point Regulatory Action Plan

October 11, 2022
Important Notice

Danger of cybersecurity attacks?

September 26, 2022
Important Notice

EU’s Implementing Regulation on Common Specifications for class D IVDs

September 6, 2022
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
MDR, News in Brief

CAMD working group publishes Q&A document regarding FSCs

July 11, 2022
News in Brief

EU has to deal with discords between AI and medical device rules

July 1, 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
News in Brief

New cybersecurity standard

April 2, 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
MDR, News in Brief

MDR harmonised standards update

February 27, 2022
COVID-19, News in Brief

New guidance for third-country manufacturers of COVID-19 IVD tests

February 6, 2022
Important Notice, IVDR

IVDR clinical evidence

February 3, 2022
MDR, News in Brief

elFU rules under the EU‘s MDR

January 26, 2022