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NEWS

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
Important Notice, News in Brief

European Commission Recommendation on Regulatory Exemptions for COVID-19 Products

March 23, 2020
News in Brief

Usability and the MDR

March 12, 2020
News in Brief

Update on Notified Bodies

March 4, 2020
Important Notice

New guidance documents for EMDN and cybersecurity

February 13, 2020
Brexit, News in Brief

Brexit and the regulatory situation for the medtech industry

February 3, 2020
News in Brief

Latest version of ISO 14971 on risk management and the MDR and IVDR

January 8, 2020
Important Notice

MDCG guidance documents on MDR codes and sampling of MDR and IVDR devices published

January 6, 2020
Important Notice

Guidance document for class I device manufacturers

December 23, 2019
Important Notice, MDR

Second MDR corrigendum published

December 18, 2019
News in Brief

Early access to Single Registration Numbers (SRN)

December 16, 2019
News in Brief

New MDR and IVDR checklists for PMS and Declaration of Conformity

December 7, 2019