Certification process for SARS-CoV-2 self-tests

In the context of the health crisis, the French and European authorities have authorized a derogation for the placing on the market of self-tests for the detection of SARS-CoV-2 by nasal swab.

This derogation, limited in time, allows the manufacturer to place the product on the European market while waiting for certification by a notified body.

GMED has been supporting these steps to protect health since the beginning of the health crisis.

These self-tests are in vitro diagnostic medical devices requiring the intervention of a notified body under Directive 98/79/EC. As such, GMED is currently experiencing a sustained number of requests from manufacturers undertaking this process. Given the criticality of these products, the conformity assessment method accepted by GMED for these medical devices combines an audit of the quality system and an examination of the technical documentation.

When applying for certification of self-tests, please provide sales@lne-gmed.com with the following information :

– Identification of the legal manufacturer, its agent (if applicable), its design and/or manufacturing subcontractor(s), and their ISO 13485 certificates (if applicable);

– The desired conformity assessment procedure according to Directive 98/79/EC;

– The form intended for the ANSM concerning the request for the placing on the market;

– The instructions for use of the self-testing device.