Tag: European Commission

European Commission Website on Regulations MDR / IVDR Restructured

August 21, 2019

The European Commission has restructured and further developed its website on the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). We strongly… Read More

New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published

August 15, 2019

by Oliver Giesemann

The European Commission has recently published a new reporting template for serious incidents under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices… Read More

Tag: European Commission

European Commission Website on Regulations MDR / IVDR Restructured

New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published

The Regulatory Affairs Network That Keeps Your Business Safe

Meet mdi Europa at Medica and Arab Health

MDCG Guidance on MDD Certificates and SSCP under the MDR