MedMira Inc. provided an update on its regulatory progress in Europe and any market accepting the CE mark. MedMira has received the CE mark for three products in 2022 and has four additional applications currently pending with the regulatory body. The Company has been informed that all applications have been accepted and will be forwarded to the Competent Authority for final CE marking.

The Company anticipates the respective decisions and CE marks within the coming weeks. With these steps, the Company has completed its application prior to the change from the In Vitro Diagnostic Medical Devices [98/79/EC: IVD] to the new In Vitro Diagnostic Medical Devices Regulation [EU 2017/746: IVDR] which was set for the 26th of May 2022. EU 2017/746: IVDR is expected to regulate around 80-90% of all In Vitro Diagnostic devices currently in the European market and introduces new scrutiny on in-vitro devices by requiring more rigorous clinical evaluations and through conformity assessments performed by a designated Notified Body.

Since the IVDR does not have provisions for grandfathering in-vitro devices, all previously approved in-vitro devices must be re-certified per the new requirements. EU 2017/746: IVDR has no short-term impact on MedMira's REVEALCOVID-19® and VYRA™ product lines since the Declaration of Conformities for these products are dated before the 26 May 2022 DoA. The long-term impact of EU 2017/746: IVDR on MedMira's products including the REVEALCOVID-19® and VYRA™ product lines is also minimal.

Rigorous testing performed on all their products, along with compliance to global standards such as MDSAP enable MedMira's products to stand out amongst their competitors in the European market. Thus, allowing MedMira to quickly transition their in-vitro devices to comply with IVDR with relative ease. Additional information regarding the transition plans will be provided in due course.