Tag: MDCG

Important Notice, IVDR

IVDR clinical evidence

February 3, 2022
IVDR, MDR, News in Brief

MDCG guidance document on distributors and importers published

December 12, 2021
MDR, News in Brief

New guidance on legacy devices published

November 12, 2021
Important Notice, MDR

New European Commission guidance document on MDR medical device classification

October 11, 2021
COVID-19

SARS-CoV-2 IVD tests and the IVDR

October 7, 2021
IVDR, MDR, News in Brief

MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services

October 4, 2021
COVID-19, News in Brief

The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD

August 5, 2021
Important Notice, IVDR

IVD or not IVD? That is the question…

April 15, 2021
Important Notice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
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