Tag: MDCG

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
Important Notice

EU guidance on Notified Body clinical evaluation assessment reports

July 24, 2020
Important Notice, MDR

Clinical evaluation and equivalence – using literature under the MDR

June 5, 2020
IVDR, MDR, News in Brief

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

June 1, 2020
Important Notice, MDR

Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

April 29, 2020
Important Notice, IVDR, MDR

MDR and IVDR guidance updates

April 9, 2020
Important Notice, MDR

Latest MDCG Preparedness Plan and MDR Delay

March 26, 2020
Important Notice

New guidance documents for EMDN and cybersecurity

February 13, 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, News in Brief

Guidance on Person Responsible for Regulatory Compliance

June 23, 2019
News in Brief

Guidance on Implant Cards

June 23, 2019
Important Notice, News in Brief

Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics

June 14, 2019
Important Notice, News in Brief

Device Registration and Legacy Devices

April 2, 2019
News in Brief

Guidance on Article 54(2)b of Regulation (EU) 2017/745 on medical devices (MDR)

March 22, 2019