Tag: COVID-19

COVID-19, News in Brief

COVID-19 tests and their risk classification

August 2, 2023
Important Notice

EU’s Implementing Regulation on Common Specifications for class D IVDs

September 6, 2022
COVID-19, News in Brief

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

February 6, 2022
COVID-19

SARS-CoV-2 IVD tests and the IVDR

October 7, 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
COVID-19, News in Brief

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

May 29, 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
COVID-19

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

November 5, 2020
COVID-19, News in Brief

Update from the European Commission for protective equipment in the COVID-19 crisis

July 20, 2020
COVID-19, News in Brief

COVID-19 In Vitro Diagnostic Devices and Test Methods Database available

July 2, 2020
COVID-19, News in Brief

European Commission guidance on surgical masks

June 29, 2020
COVID-19, Important Notice, News in Brief

Surgical and FFP masks in the COVID-19 crisis

May 8, 2020
Important Notice, MDR

MDR Postponed by One Year!

April 28, 2020
COVID-19, Important Notice

European Commission gives details of how to prevent COVID-19 test failures

April 23, 2020
Important Notice, MDR

MDR Postponement – Handle with Care!

April 21, 2020
COVID-19, Important Notice

Guidance on MD and PPE in times of COVID-19 and local provisions

April 9, 2020