Category: IVDR

IVDR, MDR, News in Brief

Get ready for the economic operator registration in EUDAMED

October 9, 2020
IVDR, MDR, News in Brief

EUDAMED economic operator registration module available as of December 2020

September 16, 2020
IVDR, MDR, News in Brief

New guidance document shows how to use MDSAP audit reports for MDR/ IVDR surveillance audits

August 21, 2020
IVDR, MDR, News in Brief

Updated Q&A document on MDR and IVDR UDI requirements from the European Commission

August 12, 2020
IVDR, MDR, News in Brief

New MDR and IVDR guidance documents published by MDCG and MedTech Europe

June 1, 2020
Important Notice, IVDR, MDR

MDR and IVDR guidance updates

April 9, 2020
Important Notice, IVDR

Performance Evaluation for IVD Medical Devices

October 28, 2019
CE Consulting, IVDR, MDR

Notified Body Selection and Change

December 15, 2018