Author: Oliver Giesemann

News in Brief

UDI helpdesk website published

April 13, 2023
News in Brief

News on guidance documents

March 3, 2023
News in Brief

EU notified bodies on harmonised standards regarding cybersecurity

January 6, 2023
News in Brief

Cybersecurity in the EU

November 8, 2022
Important Notice

Different options for IVD medical devices until Eudamed becomes fully operational

September 2, 2022
Important Notice, IVDR, MDR

Updated Blue Guide and MDR and IVDR harmonized standards

July 14, 2022
MDR, News in Brief

CAMD working group publishes Q&A document regarding FSCs

July 11, 2022
Important Notice, IVDR, MDR

EUDAMED update on timelines

April 10, 2022
News in Brief

New cybersecurity standard

April 2, 2022
Important Notice, IVDR

IVD medical devices after the IVDR date of application

March 12, 2022
IVDR, News in Brief

New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices

March 4, 2022
COVID-19, News in Brief

New guidance for third-country manufacturers of COVID-19 IVD tests

February 6, 2022
Important Notice, IVDR, MDR

European Commission EUDAMED website expanded

December 6, 2021
IVDR, MDR, News in Brief

IEC about to publish new standard on cybersecurity

November 10, 2021
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
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
COVID-19, News in Brief

Guidance document on the impact of genetic variants on SARS-COV-2

May 29, 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, 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
COVID-19, News in Brief

Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons

March 8, 2021
COVID-19, News in Brief

European Commission publishes Q&A guidance on COVID-19 tests

March 1, 2021
IVDR, MDR, News in Brief

Voluntary registration with EUDAMED database – industry fears duplicate registrations

January 23, 2021
COVID-19

Defined performance criteria for rapid SARS-CoV-2 antigen tests

November 5, 2020
IVDR, MDR, News in Brief

New website on actor registration in EUDAMED 3 available

October 29, 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