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Update on the new In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Market

Halifax, Nova Scotia, 27 May, 2022 – Today, MedMira Inc. (MedMira) (TSXV: MIR) provides 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. As of today, 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.

“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.

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.

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Regulatory AffairsIn Vitro DiagnosticsCE Mark
MedMira Inc.

Markus Meile

Chief Financial Officer

ir@medmira.com

Phone 902-450-1588

Privacy Policy

Last updated: April 20, 2026

MedMira Inc. (“MedMira”, “we”, “us”, or “our”) is committed to protecting personal information in accordance with applicable privacy laws, including the Personal Information Protection and Electronic Documents Act (PIPEDA) in Canada, as well as applicable United States and international privacy requirements.

This Privacy Policy describes how we collect, use, disclose, and safeguard personal information through our website. Our website is primarily informational in nature and does not provide user accounts, applications, or diagnostic services.

1. Personal Information We Collect

We collect personal information only where it is voluntarily provided by you. “Personal information” means information about an identifiable individual. The types of personal information we may collect include:

a) Contact Forms
When you submit an inquiry, we may collect your first and last name, email address, phone number (optional), organization (optional), inquiry details, selected topic, and message, as well as your self-identified category (e.g., partner, healthcare provider, researcher, investor, media, or other).

b) Newsletter Subscription
If you subscribe to receive updates, we may collect your email address and, where provided, your category or area of interest.

c) Communications
We may retain records of communications you send to us, including emails and inquiries, in order to respond to you and maintain appropriate business records.

We collect personal information directly from you and do not knowingly obtain personal information from data brokers or unrelated third-party sources.

If you provide personal information relating to another individual, you represent that you have the authority to do so and that such information may be used in accordance with this Privacy Policy.

We do not intentionally collect sensitive personal information or collect more information than necessary for the purposes described herein.

2. Purposes of Collection and Use

MedMira collects and uses personal information for limited and legitimate business purposes, including responding to inquiries, communicating with you, providing information about our company and activities, delivering newsletters or updates where you have opted in, maintaining internal records, and complying with applicable legal and regulatory obligations.

We do not use personal information for profiling, automated decision-making, or targeted advertising.

3. Consent

By submitting personal information to MedMira, you consent to its collection, use, and disclosure as described in this Privacy Policy.

Where required by applicable law, you may withdraw your consent at any time, subject to legal or contractual restrictions and reasonable notice. Withdrawal of consent may limit our ability to respond to your inquiry or provide requested information.

4. Cookies and Similar Technologies

MedMira’s website does not use cookies, analytics tools, or tracking technologies for advertising or behavioral tracking purposes.

However, our website may include content or links to third-party platforms, such as LinkedIn, X (formerly Twitter), or YouTube. Interaction with such content (including embedded media or external links) may result in those third parties placing cookies or using similar technologies on your device.

MedMira does not control and has no access to data collected through such third-party technologies.

5. Disclosure of Personal Information

MedMira does not sell, rent, or trade personal information.

We may disclose personal information to third parties only in limited circumstances, including to service providers acting on our behalf (such as email distribution providers), who are contractually required to protect the information and use it only for the intended purposes.

We may also disclose personal information where required by law, regulation, legal process, or to protect the rights, property, or safety of MedMira or others, or in connection with a corporate transaction where permitted by law.

6. Third-Party Websites and External Services

Our website may contain links to or integrations with third-party services, including but not limited to Google Maps, SEDAR (System for Electronic Document Analysis and Retrieval), PubMed, LinkedIn, X (formerly Twitter), and YouTube.

These services are operated by independent third parties. When you access or interact with such services, your personal information may be collected and processed directly by those third parties in accordance with their own privacy policies.

MedMira does not control and assumes no responsibility or liability for the privacy practices, content, or data handling activities of third-party services. Accessing such services is at your own risk.

7. Data Retention

We retain personal information only for as long as necessary to fulfill the purposes for which it was collected, including responding to inquiries, maintaining communication records, and providing newsletters.

Personal information associated with newsletter subscriptions is retained until you unsubscribe. We may retain information for longer periods where required to comply with legal obligations or to establish, exercise, or defend legal claims.

8. Safeguards and Security

MedMira implements reasonable administrative, technical, and organizational safeguards appropriate to the sensitivity of the information to protect personal data against loss, theft, unauthorized access, disclosure, copying, use, or modification.

However, no method of transmission over the Internet or electronic storage is completely secure. While we take appropriate steps to protect personal information, we cannot guarantee absolute security, and any transmission of information is at your own risk.

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MedMira is headquartered in Canada but may engage service providers located in other jurisdictions, including the United States. As a result, personal information may be transferred to and processed in jurisdictions outside your country of residence.

Such jurisdictions may have different data protection laws and may permit access by governmental authorities under applicable laws. By providing your personal information, you consent to such transfers where permitted by law.

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Subject to applicable law, you may have the right to access, correct, or request deletion of your personal information, withdraw your consent to processing, or opt out of receiving communications.

To exercise your rights, please contact us using the contact details below. We will respond to requests in accordance with applicable legal requirements.

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Our website is accessible to individuals of all ages but is not specifically directed at children. We do not knowingly collect personal information from children without appropriate consent.

If you believe that a child has provided personal information to us, please contact us so that we can take appropriate steps to remove such information where required.

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To the fullest extent permitted by applicable law, MedMira disclaims liability for the privacy practices, actions, or omissions of third parties, including external websites and service providers not under our direct control.

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MedMira reserves the right to update or modify this Privacy Policy at any time. Any changes will be posted on this page with a revised “Last updated” date. Continued use of the website following such changes constitutes acceptance of the updated Privacy Policy.

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For questions, requests, or concerns regarding this Privacy Policy or our data practices, please contact:

MedMira Inc.
155 Chain Lake Drive, Suite 1
Halifax, Nova Scotia B3S 1B3
Canada

Email: info@medmira.com
Phone: +1 (902) 450 1588
Toll Free: +1 (877) 633 6372

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Committed to quality
Certified & Proven Quality

Our quality management system is ISO 13485:2016 certified, compliant with the United States Food and Drug Administration’s current Good Manufacturing Practices (cGMP: Quality System Regulation Part 820 of CFR Title 21, Volume 8), European Union’s Directive 98/79/EC on in vitro diagnostic medical devices, and Health Canada Medical Device Regulations (SOR/98-282).

Additionally, we adhere to ISO 14971 (Application of Risk Management to Medical Devices) and ISO 2859 (Sampling Procedures for Inspection by Attributes). Certification and compliance to these requirements attests to our ability to maintain the highest standard of quality in medical device manufacturing, product development and corporate conduct.

Our products have been approved by regulators and UN agencies worldwide.

FDA

Health Canada

International Trade Centre (ITC)

Pan American Healtch Organization (PAHO)

UN Development Programme (UNDP)

UN Office for Project Services (UNOPS)

UN Office at Vienna (UNOV)

UN Population Fund (UNFPA)

United States Agency for International Development (USAID)

CFO & Head of Commercialization

Markus Meile

Markus joined MedMira in 2010, and moved into the role of Chief Financial Officer in 2014.

He previously served on the Company’s Board of Directors, as a member of the Audit Committee, and as the Senior Director of International Markets.

Prior to joining MedMira, Markus worked with a number of financial institutions in Switzerland, England, and Hong Kong. He holds a BSc from Royal Holloway University of London and has studied business management, strategic planning, investment and accounting at business school in Zurich. Previously, Markus worked in the medical device industry in Africa, Asia Pacific, and Europe.

He will combine his financial expertise with his broad range of international business knowledge to build financial and corporate strategies supporting MedMira’s continuing growth and increasing shareholder value.

Director of the Audit Committee, Nomination and Compensation Committee

Jianhe Mao

Jianhe Mao is the owner of Unipec, a consulting firm based in St. Gallen, Switzerland. Unipec focuses on helping European companies enter the Chinese market, through operational restructuring and ownership and management optimization.

In addition to leading Unipec, Mr. Mao is involved in several industrial projects and start-up ventures including Monsatec AG, a new company bridging the gap between laboratories and clinics with a cold plasma medical device. He serves on the boards of several European companies and is regarded as a trusted expert in legal cases, corporate corruption, operational turnarounds, and mergers and acquisitions.

Mr. Mao began his career as a project engineer and has gained experience in business development and real estate investment. He holds M.E. from Ruhr University Bochum.

CEO, Co-Founder & Co-Inventor

Hermes Chan, D.Sc. (h.c.)

Hermes Chan, our Chief Executive Officer and Co-Founder, leads our passionate and committed team in driving the strategic direction and growth of MedMira.

Hermes, who was named BioScience Innovator of the Year by The Economist in 2007, is the inventor of our patented rapid flow-through diagnostic technology platform.

Since the company’s inception in 1994 Hermes has held progressively senior management roles including Research Scientist, General Manager, Senior Vice President, and Chief Operating Officer.

Prior to creating MedMira, Hermes worked with another Canadian biotechnology company in the diagnostics research sector.

Chair member of the Audit Committee, Nomination and Compensation Committee

Steven Cummings

Mr. Steven Cummings is the Founder & President of Cambridge Financial Services, one of the leading full service accounting, tax, and business advisory firms in Nova Scotia.

Under Mr. Cummings leadership, Cambridge Financial has earned an enviable reputation among businesses and industry for a commitment to high standards. Along with his leadership responsibilities at Cambridge Financial Services, Mr. Cummings was engaged as MedMira’s interim Chief Financial Officer in 2007.

With more than 30 years of financial and entrepreneurial experience, Mr. Cummings is a frequent guest speaker on issues surrounding provincial taxation, taxation of seniors, and business ownership

Intellectual property

China

ZL02819646.5

Rapid Diagnostic Device and Assay

Intellectual property

European union

EP1417489

Rapid Diagnostic Device and Assay

EP1328811

HCV Mosaic Antigen Composition (2021)

Intellectual property

USA

9,164,087

Rapid Diagnostic Device, assay and multifunctional Buffer

9,086,410

Downward or vertical flow diagnostic device and assay

8,025,850

Rapid Diagnostic Device, Assay and Multifunctional Buffer

8,287,817

Rapid Diagnostic Device, Assay and Multifunctional Buffer

8,586,375

Rapid Diagnostic Device, Assay and Multifunctional Buffer

7,531,362

Rapid Diagnostic Device, Assay and Multifunctional Buffer

D706945

Diagnostic Device

D706466

Diagnostic Device

11,353,450

Analyte Detection Using Raman Spectroscopy

Intellectual property

Canada

CA2,493,616

Rapid Diagnostic Device, Assay and Multifunctional Buffer

CA2,740,902

Downward or Vertical Flow Diagnostic Device and Assay

CA2,949,634

Analyte Detection Using Raman Spectroscopy

MiROQ Vision

Handheld Device

A future concept built on the same MIROQ technology, designed to deliver lab-grade precision in the palm of your hand.

We envision a future where testing can happen anywhere, anytime – from hospitals and clinics to remote regions or even at home – enabling early disease detection and turning knowledge into real impact. No large equipment or complex infrastructure required.

For: Doctor’s offices, small and mobile clinics

Future application: Home use

Connectivity: Bluetooth, Wifi and USB