Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 535

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 535
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 and their manufacturers with the General Safety and Performance Requirements must be based, among other
things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically,
a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use and that the known and
foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance,
and that any claims made about the performance and safety of the device (e.g., product labeling and instructions for use) are supported
by suitable evidence. This assessment must be based on clinical data, which can be obtained from (1) clinical studies conducted on the
devices being assessed, (2) scientific literature from similar devices whose equivalence with the assessed device can be demonstrated
or (3) both clinical studies and scientific literature. The conduct of clinical studies in the EEA is governed by detailed regulatory
obligations. These may include the requirement of prior authorization by the competent authorities of the country in which the study takes
place and the requirement to obtain a positive opinion from a competent Ethics Committee. This process can be expensive and time-consuming.

The EU MDR repeals and replaces
the EU Medical Devices Directive 93/42/EEC. Unlike directives, which must be implemented into the national laws of the EEA countries,
the regulations is directly applicable, i.e., without the need for adoption of EEA country laws implementing them, in all countries and
are intended to eliminate current differences in the regulation of medical devices among EEA countries. The EU MDR, among other things,
establishes a uniform, transparent, predictable and sustainable regulatory framework across the EEA for medical devices and ensures a
high level of safety and health while supporting innovation. The EU MDR entered into application on May 26, 2021, and among others things:

    ●
    strengthens the rules on placing devices on the market and reinforce surveillance once they are available;

    ●
    establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

    ●
    improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

    ●
    sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;

    ●
    strengthens rules for the assessment of certain high-risk devices which may have to undergo an additional check by