On 3 August 2021, the EU Coordinating Group on Medical Devices (MDCG) published guidance MDCG 2021-21 for the performance evaluation of SARS-COV-2 in vitro diagnostic Devices.
This guideline covers the performance evaluation of SARS-COV-2 IVD products under IVDD 98/79/EC or IVDR (EU) 2017/746. It covers the detailed requirements for nucleic acid test reagents, antigen reagents and antibody reagents for COVID-19, such as sample requirements and acceptance criteria, as shown in the table below. It can be used for reference by various stakeholders including manufacturers, notified bodies, competent authorities and authorized representatives.
In addition, the guidance states that its content will form the basis of the common specification CS for SARS-COV-2 IVD products under IVDR, which will be adopted and implemented in the coming months. From the perspective of COVID-19 manufacturers, it is important to familiarize themselves with the requirements as early as possible in order to register under the existing directive or prepare for class D certification.
