The Medical Device Coordination Group has just published the MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices for conformity assessment under Directive 98/79/EC or Regulation (EU) 2017/746. This includes devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens and also detection or quantification of antibodies against SARS-CoV-2.
The guidance is intended for all interested parties, including but not limited to manufacturers, notified bodies, competent authorities, authorized representatives, other market operators, and professional and patient associations.
It is considered that the content of this guidance document will form the basis of the common specifications to be adopted in accordance with Article 9 of Regulation (EU) 2017/746 in the coming months. The content may be adapted to take into account changing circumstances and increasing scientific and technical knowledge as the COVID-19 pandemic evolves.