Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 534

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 534
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, subject to regulation by the Department of Transportation, the International
Air Transportation Association, the International Maritime Organization, the Environmental Protection Agency and the Occupational Safety
and Health Administration, which may impose various requirements pertaining to the way we manufacture, transport, store, handle and dispose
of our products. At this time, we have no material costs associated with environmental laws.

European Regulation of Medical
Devices. In the European Economic Area (“EEA”), we expect our products to be regulated as a medical device product falling
within the scope of EU MDR.

In the EEA, medical devices must
currently comply with the General Safety and Performance Requirements laid down in Annex I to the EU MDR. Compliance with these requirements
is a prerequisite to be able to affix the CE mark on products, without which they cannot be marketed or sold in the EEA. To demonstrate
compliance with the General Safety and Performance Requirements of the EU MDR and obtain the right to affix the CE mark, medical devices
manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its classification.
Apart from low risk medical devices (Class I with no measuring function and which are not sterile), in relation to which the manufacturer
may issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the General Safety and Performance
Requirements, a conformity assessment procedure requires the intervention of a notified body, which is an organization designated by a
Competent Authority of an EEA country to conduct conformity assessments. Depending on the relevant conformity assessment procedure, the
notified body would audit and examine the technical documentation and the quality system for the manufacture, design and final inspection
of the medical devices. The notified body issues a CE Certificate of Conformity following successful completion of a conformity assessment
procedure conducted in relation to the medical device and its manufacturer and their conformity with the General Safety and Performance
Requirements. This Certificate and the related conformity assessment process entitles the manufacturer to affix the CE mark to its medical
devices after having prepared and signed a related EC Declaration of Conformity. Notified bodies must be accredited by the EEA countries’
accreditation bodies to conduct assessment procedures for medical devices in accordance with the EU MDR. There are currently a relatively
small number of notified bodies that have been accredited to conduct these assessments. This may delay conformity assessment procedures
in the future in the EU.

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As a general rule, demonstration
of conformity of medical devices