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Impact of MDCG 2021-21 on SARS-CoV-2 IVDs
Recently, the Medical Device Coordination Group (MDCG) has published a new document (MDCG 2021-21) to guide MedTech stakeholders in the performance
What is the status of the COVID-19 rapid tests in the EU/EEA?
In-vitro diagnostic tests for detecting the coronavirus is an essential tool in slowing the
Humanitarian Exemption and Emergency Approval Scenarios
United States - European Union Exceptional regulatory situations have been allowed recently due to the coronavirus pandemic. Exceptional
Free Resources for the Medical Device Industry to Fight COVID-19
Do you want to place your medical device or in-vitro diagnostic device on the market, but you have limited resources to do so? We prepared this
ÅKRN is Joining The Fight Against COVID-19
ÅKRN is a European Medical Device and In-Vitro Diagnostics CRO that can help your company get clinical trial approval / EU market approval To
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