In brief
In January 2022, the Medical Device Coordination Group (MDCG) published a notice addressed to manufacturers of in vitro diagnostic medical devices (IVDD) with the intended purpose to detect and/or quantify markers of SARS-CoV-2 infection based in non-EU countries and who place such products on the EU market. The purpose of the notice is to address some issues identified by EU national authorities in the course of their surveillance activities on the compliance of such devices with the requirements of Directive 98/79/EC on IVDD.
Firstly, the notice clarifies that manufacturers must designate an authorized representative based within the EU territory, whose task is to notify the competent authorities of the address of the manufacturer’s registered place of business as well as the information relating to the device referred to in Article 10 of the IVDD.
The notice also draws manufacturers’ attention to the need to correctly translate the instructions for use and the label accompanying the device into the languages of the Member States in which the device is marketed.
Lastly, the notice specifies that, while manufacturers of diagnostic devices for detecting SARS-CoV-2 infection placed on the market pursuant to the IVDD must lodge an application with a notified body for the assessment of its quality management system only with respect to products intended for lay users, for all in vitro diagnostic medical devices placed on the market pursuant to Regulation (EU) 2017/746 manufacturers must request the conformity assessment by a notified body.
