Theme Compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC or Regulation (EU) 2017/746.
Target Audience Manufacturers of IVDs for the detection/quantification of markers of SARS-CoV-2 infection established outside the EU or EEA and intending to place their devices on the EU market.
Products concerned


Documents mentioned

IVDD 98/79/EC

IVDR (EU) 2017/746

MDCG 2021-21

MDCG 2021-26

Competent authorities have raised common issues regarding the compliance of SARS-CoV-2 IVDs with Directive 98/79/EC during their market surveillance activities. In this context, MDCG 2022-1 recalls few requirements applicable to this type of device, such as the designation of an authorised representative, the intervention of a notified body for SARS-CoV-2 self-tests under the Directive, the translation of the instructions for use and of the label accompanying the device. It also recalls the existence of a guide dedicated to the evaluation of the performance of the different types of SARS-CoV-2 IVDs (MDCG 2021-21)

The end of the document is devoted to the transition from Directive 98/79/EC to Regulation (EU) 2017/746 and recalls in particular the transitional provisions provided for in Article 110 of the IVDR.