17.01.2022
To the attention of all stakeholders (importers, distributors, users)
The NAMMDR warns all stakeholders not to introduce on the Romanian market or to use medical devices of type CoviSelf COVID-19 Antigen Lateral Flow Test Device OTC Home Test, manufactured by MyLab Discovery Solutions PVT LTD, India, for which they have received the falsified EC certificate of conformity no. 1434-IVDD-648/2021 which would have been issued by Notified Body Polish Centre for Testing and Certification, Poland (1434) on 30.11.2021, valid until 30.11.2024.
To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, please check the NAMMDR website for such information and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95/2006 on healthcare reform, republished, as further amended and supplemented.