Tag: IVDR

Important Notice, IVDR, MDR

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

March 15, 2021
IVDR, MDR, News in Brief

Voluntary registration with EUDAMED database – industry fears duplicate registrations

January 23, 2021
Important Notice

Key guidance document on the classification of IVDs under the IVDR

December 1, 2020
IVDR, News in Brief

EU IVD medical devices sector destined for crisis?

November 6, 2020
IVDR, MDR, News in Brief

New website on actor registration in EUDAMED 3 available

October 29, 2020
IVDR, MDR, News in Brief

Practical advice for setting up an MDR and IVDR compliant PMS Plan

October 22, 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
IVDR, MDR, News in Brief

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

August 12, 2020
News in Brief

Relocation of the European Commission website on medical devices

June 30, 2020
MDR, News in Brief

Updated timetable for Eudamed

June 7, 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
News in Brief

Usability and the MDR

March 12, 2020
Important Notice

New guidance documents for EMDN and cybersecurity

February 13, 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
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
News in Brief

News on symbols to be used under the MDR and IVDR

December 5, 2019
News in Brief

Technical Documentation format under the MDR and IVDR

December 1, 2019
Important Notice, News in Brief

News on EUDAMED

November 7, 2019
News in Brief

DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR

November 6, 2019
News in Brief

Guidance on Qualification and Classification of Software under the MDR and IVDR Published

October 28, 2019
Important Notice, IVDR

Performance Evaluation for IVD Medical Devices

October 28, 2019
News in Brief

New Notified Bodies Designated under the MDR and IVDR

October 15, 2019
Important Notice, News in Brief

European Commission Website on Regulations MDR / IVDR Restructured

August 21, 2019
News in Brief

Most Important Changes – Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)

July 16, 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