Tag: IVDR

COVID-19

SARS-CoV-2 IVD tests and the IVDR

October 7, 2021
Important Notice, IVDR, MDR

EUDAMED UDI/Devices and NBs/Certificates modules now live

October 6, 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
News in Brief

The IVDR and performance evaluation studies

July 8, 2021
IVDR, MDR, News in Brief

New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR

July 4, 2021
IVDR, MDR, News in Brief

Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN

June 15, 2021
IVDR, MDR, News in Brief

EU UDI helpdesk available

June 10, 2021
IVDR, MDR, News in Brief

Standard ISO 20417:2021 for the MDR and IVDR published

June 3, 2021
IVDR, MDR, News in Brief

EU clearance for MDR and IVDR harmonised standards

May 28, 2021
IVDR, MDR, News in Brief

EU – Switzerland MRA expired

May 27, 2021
IVDR, MDR, News in Brief

Guidance on legacy devices regarding Eudamed

May 3, 2021
Important Notice, IVDR, MDR

New guidance documents published by the European Commission

May 2, 2021
Important Notice, IVDR

IVD or not IVD? That is the question…

April 15, 2021
Important Notice, IVDR, MDR

Updated EUDAMED implementation dates

April 1, 2021
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