Medical Device Coordination Group (MDCG) has released guidance for performance evaluation of devices collectively referred to as SARS-CoV2 IVDs. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
Released guidance covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens and also detection or quantification of antibodies against SARS-CoV-2. And it is addressed to all interested parties, including notably the manufacturers, as well as notified bodies and competent authorities, authorized representatives, other market operators, professional and patient associations.The content of released guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months.
As a general rule from the guidance document, the performance evaluations of SARS-CoV-2 tests should be carried out in direct comparison with a state-of-the-art device and should be performed on a population equivalent to the European population.
Check out the guidance document from EU-commission webpage: https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-21_en.pdf