The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...
The World Health Organization (WHO), the international organization focused on public health protection, issued a notice providing medical device manufacturers and industry representatives additional information that addresses COVID-19-related issues. The document...
The European Commission, the EU authority responsible for medical device regulation, issued guidelines dedicated to the diagnostic tests used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. The...
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulation, issued guidance highlighting the performance requirements applicable to ventilators used in Australia during the outbreak of the Coronavirus Disease 2019...