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To: jim heger who wrote (49342)

5/27/2022 6:06:04 PM

From: Dick Martin

of 49402

MIR - Medmira seems to be well placed right now. Been going for years and was struggling with regulatory approval and marketing is starting showing good promise. today's press release:

MedMira Provides Update on New In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Market

27 May 2022 09:19 ET
09:19 AM EDT, 05/27/2022 (MT Newswires) -- MedMira Inc. (MIR.V) on Friday provided an update on its regulatory progress in Europe and any market accepting the CE mark. The company has received the CE mark for three products in so far this year and has four additional applications pending with the regulatory body. As of today, Medmira has been informed that all pending applications have been accepted and will be forwarded for final CE marking. MedMira anticipates the respective decisions and CE marks in the coming weeks.

The company has now completed its application ahead of the change from the In Vitro Diagnostic Medical Devices to the new In Vitro Diagnostic Medical Devices Regulation (IVDR), set for May 26 2022. IVDR is expected to regulate around 80-90% of all In Vitro Diagnostic devices currently in the European market and requires more rigorous clinical evaluations and thorough conformity assessments performed by a designated Notified Body.

"The new IVDR regulations are going to have a significant impact on the overall market in terms of regulatory approval. It will be more challenging to achieve an approval and manufacturers will have to show more to get access to the CE market. In short; the entry barriers will be higher, and the quality of the products and the manufacturer will be at the focus of the regulatory bodies. This is going to change the competitive landscape in our favour and we are delighted to have all our current and pending products ready for this change," said Hermes Chan, CEO of MedMira Inc.

All previously approved in-vitro devices must be re-certified per the new requirements. IVDR has no short-term impact on MedMira's REVEALCOVID-19 and VYRA product lines.

The long-term impact of IVDR on MedMira's products including the two above-mentioned product lines is also minimal. The company says it will be able to quickly transition the in-vitro devices to comply with IVDR with relative ease.

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