Rhinomed is pleased to announce it has been advised by Medical Device Safety Service GmbH (MDSS) that an Authorized Representative’s Mandate according to the EU Regulation 2017/745 (MDR) is in place. As a result, Rhinomed has been issued a CE Certificate No.: 431330 for the new Rhinoswab.
The successful registration and conformity with the relevant standards means that Rhinomed’s novel nasal swab (the Rhinoswab) is now able to be sold in the European market. The CE Mark follows the successful registration of the Rhinoswab with the US FDA and its inclusion on the ARTG in Australia.
The new nasal swab is an extension of Rhinomed’s nasal technology platform and intellectual property patent portfolio using the company’s depth of experience as a world-leading developer of nasal devices. Rhinomed’s existing nasal products have been worn comfortably and safely since 2016 and are sold in over 20,000 pharmacies worldwide. The new Rhinoswab is:
- Less invasive and more comfortable than standard nasal swabs;
- Unique as it collects samples from both nostrils simultaneously;
- Able to collect a larger sample and elute this for testing more efficiently than existing standard of care nasal swabs;
- Able to be self-administered easily, anywhere, potentially reducing the risk of infection of healthcare workers;
- Validated in the lab to work with both RT-PCR and point of care antigen tests
Rhinomed’s nasal swab is designed for self-collection in the home, workplace or in a clinical setting under supervision and is expected to address the problems with current nasal swabs that are highly invasive and uncomfortable. Most existing nasal swabs require a healthcare worker to collect the sample, which places the healthcare worker at risk of infection. The use of healthcare workers and the requisite personal protection equipment (PPE) also comes with significant cost.
The new Rhinomed swab is designed to be able to collect a larger sample, be worn for a predetermined time (it fits snugly in place) and collect a sample from both nostrils simultaneously, thus offering the potential for a more effective diagnostic sample. The swab has been designed to fit into existing vials and work with existing pathology workflows.
The Company is now vigorously scoping manufacturing sites and volumes in anticipation of global demand.