Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 779

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 779
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 EU MDR conformity assessment is substantially longer than under the previous Directive
(currently between 13 and 18 months in average). This may delay conformity assessment procedures in the future in the EEA, and may impact
any of our future activities in the EEA and the UK, the renewal of our existing CE Certificates of Conformity and conformity assessment
related to future bodies.

Further, the EU MDR imposes increased
compliance obligations for us to access the EEA market. Our failure to comply with applicable foreign regulatory requirements, including
those administered by authorities of the EEA countries, could result in enforcement actions against us, including refusal, suspension,
variation, or withdrawal of any CE Certificates of Conformity by the applicable EU notified body, which could impair our ability to market
products in the EEA. Any changes to the membership of the EU, such as the departure of the United Kingdom (Brexit), may impact the regulatory
requirements for the impacted countries and impair our business operations and our ability to market products in such countries.

Brexit has created significant
uncertainty concerning the future relationship between the UK and the EU. On 24 December 2020, the EU and UK reached an agreement in principle
on the framework for their future relationship, the EU-UK Trade and Cooperation Agreement (the “Trade Agreement”), which took
effect on May 1, 2021. The Trade Agreement primarily focuses on ensuring free trade between the EU and the UK in relation to goods. The
Trade Agreement does not however, specifically address medical devices. The Trade Agreement seeks to ensure that the parties ensure “regulatory
cooperation”. Among the changes that will now occur are that Great Britain (England, Scotland and Wales) will be treated as a third
country. Northern Ireland will, with regard to EU regulations, continue to follow the EU regulatory rules. In light of the fact that the
CE marking process is set out in EU law, which no longer applies in the UK, the UK has devised a new route to market culminating in a
UK Conformity Assessed (“UKCA”) mark to replace the CE mark. Northern Ireland will, however, continue to be covered by the
regulations governing CE marks. As part of the Trade Agreement, the EU and the UK have agreed to continue to recognize declarations of
conformity based on a self-assessment in the other territory. On July 1, 2023, The UK Medical Device Regulations 2002 (SI