SELFCHECK is a registered trademark of JR Biomedical Ltd and represents a premium brand range of easy to use, high quality in-vitro diagnostic devices for self testing, assembled under a full quality assurance system certified to ISO13485:2016 at our laboratories in St Asaph, North Wales - backed with expert customer care. Our SELFCHECK medical tests for self test use are regulated by the In Vitro Diagnostics Directive/Regulations (IVDD/ IVDR) and CE marked specifically for self test use.
Key drivers for the UK self testing market include; constraints on NHS budgets, growing awareness of the availability of self test kits, convenient access through pharmacies, supermarkets and online health product retailers, ease of use, familiarity of the general public with lateral flow devices and reliability, acknowledgement of clinicians for the beneficial effects of self testing on early diagnosis and self care, and the availability of a strong brand - SELFCHECK.
Although the introduction of new regulations in the UK for medical diagnostic devices will provide more protection for users of medical devices, it also means an increased burden not only for manufacturers but also for distributors and retailers as well. Distributors will need to demonstrate that they have resources and medical device quality systems, such as ISO13485:2016, in order to comply with the new regulations. Those greatest impacted by the new regulations are likely to be distributors operating on low margins and an inability or failure to plan and invest in compliance.
A pipeline of new products will see the SELFCHECK range double in number since the brand was acquired in 2018, and also the development of a new biomarker for use by clinicians in hospitals for the diagnosis of sepsis with a prototype ready in 2022.