MedMira provides an update on the new In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Market
27 Mayo 2022 - 7:01AM
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.
Next Update:A next update will
be provided on the 3rd of June 2022.
About MedMira
MedMira is a leading developer and manufacturer
of Rapid Vertical Flow® diagnostics. The Company’s tests provide
hospitals, labs, clinics and individuals with instant disease
diagnosis, such as HIV, Syphilis, Hepatitis, and SARS-CoV-2, in
just three easy steps. The Company’s tests are sold globally under
the REVEAL®, REVEALCOVID-19®, Multiplo® and Miriad® brands. Based
on its patented Rapid Vertical Flow® Technology, MedMira’s rapid
HIV test is the only one in the world to achieve regulatory
approvals in Canada, the United States, China and the European
Union. MedMira’s corporate offices and manufacturing facilities are
located in Halifax, Nova Scotia, Canada. For more information visit
medmira.com. Follow us on Twitter and LinkedIn.
This news release contains forward‐looking
statements, which involve risk and uncertainties and reflect the
Company’s current expectation regarding future events, including
statements regarding possible regulatory approval, product launch,
future growth, and new business opportunities. Actual events could
materially differ from those projected herein and depend on a
number of factors including, but not limited to, changing market
conditions, successful and timely completion of clinical studies,
uncertainties related to the regulatory approval process,
establishment of corporate alliances and other risks detailed from
time to time in the company quarterly filings.
Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
MedMira ContactMarkus MeileChief
Financial Officer MedMira Inc.ir@medmira.com
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