Company: NYXH
Filing Date: 2025-08-11
Form Type: 6-K
Source: 0001104659-25-075831
Chunk: 9

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 9
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 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, 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 are supported by suitable evidence. We obtained CE-Mark certification for the Genio system
in March 2019. However, if we fail to remain in compliance with applicable European laws and directives and corresponding EU member state
laws, we would be unable to continue to affix the CE-Mark to our products, which would prevent us from selling them within the EU.

The aforementioned EU rules
are generally applicable in the European Economic Area, or EEA, which consists of the 27 EU member states plus Norway, Liechtenstein and
Iceland. Noncompliance with the above requirements would also prevent us from selling our products in these three countries.

Following the end of the
“Brexit” transition period, from January 1, 2021 onwards, the UK Medicines and Healthcare products Regulatory Agency, or MHRA
is responsible for the UK medical device market. The new regulations require medical devices to be registered with the MHRA, (but manufacturers
are given a grace period of four to 12 months to comply with the new registration process). Manufacturers based outside the UK must appoint
a UK Responsible Person to register devices with the MHRA in line with the grace periods. The UK will continue to recognize CE-Markings,
as well as certificates issued by EU recognized Notified Bodies, until the earlier of June 30, 2028 or the expiration of the certificate
for devices compliant with the Medical Devices Directive or the Active Implantable Medical Devices Directive, or until June 30, 2030 for
devices compliant with the MDR. Devices marketed in the UK (England, Scotland, and Wales) after such respective dates will require a UK
Conformity Assessed, or UKCA, mark. However, UKCA marking alone will not be recognized in the EU. In addition, the rules for placing medical
devices on the Northern Ireland market differ from those in the rest of the UK.

In order to sell products
in Switzerland, manufacturers based in the EU must appoint a Swiss Authorized Representative, or CH-Rep.

The FDA or foreign regulatory
authorities