Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 778

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 778
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 are not able to maintain regulatory compliance, we may lose any marketing clearance that we may have obtained and
we may not achieve or sustain profitability.

49

In addition, on May 25, 2017, the new
EU MDR entered into force for medical devices marketed in the EEA. Implementation of the EU MDR was delayed by one year due to the COVID-19
pandemic. Following its entry into application on May 26, 2021, the EU MDR introduced substantial changes to the obligations with which
medical device manufacturers must comply in the EEA. High risk medical devices are subject to additional scrutiny during the conformity
assessment procedure. Specifically, the EU MDR repeals and replaces the EU Medical Devices Directive. 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 EEA countries and are intended to eliminate current differences in regulation of medical
devices among EEA countries. The EU MDR, among other things, is intended to establish a uniform, transparent, predictable and sustainable
regulatory framework across the EEA for medical devices to ensure a high level of safety and health while supporting innovation. The
EU MDR entered into application on May 26, 2021 and among other 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 EEA; and

    ●
    strengthens rules for the assessment of certain high-risk devices which may have to undergo an additional check by experts before they are placed on the market.

The EU MDR imposes a number of
new requirements on manufacturers of medical devices. Notified bodies need to be accredited by the EU Member States’ 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 and their capacity to deal with new applications is currently
limited. In addition, the timeline to go through an