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NEWS

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
Important Notice, IVDR

European Commission proposal for progressive roll-out of the IVDR adopted

January 5, 2022
News in Brief

New artificial intelligence regulations could lead to unnecessary burdens

December 29, 2021
MDR, News in Brief

bsi white paper on clinical evaluations

December 15, 2021
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
Brexit, News in Brief

Consultation on amending UK medical devices regulations

December 2, 2021
MDR, News in Brief

New guidance on legacy devices published

November 12, 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, MDR

New European Commission guidance document on MDR medical device classification

October 11, 2021