Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 146

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 146
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. There are also harmonized standards relating to design and manufacture. While not mandatory, compliance
with these standards is viewed as the easiest way to satisfy the general safety and performance requirements as a practical matter, as
it creates a rebuttable presumption that the device satisfies the general safety and performance requirements.

To demonstrate compliance
with the general safety and performance requirements we must undergo a conformity assessment procedure, which varies according to the
type of medical device and its (risk) classification. As a general rule, demonstration of conformity of medical devices 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, 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. Except for low-risk medical devices (Class I), where the manufacturer can issue an European
Community Declaration of Conformity based on a self-assessment of the conformity of its products with the general safety and performance
requirements (except for any parts which relate to sterility, metrology or reuse aspects), a conformity assessment procedure requires
the intervention of an organization accredited or designated by a member state of the EU to conduct conformity assessments, or a notified
body. Depending on the relevant conformity assessment procedure, the notified body would typically audit and examine the technical file
and the quality system for the manufacture, design and final inspection of our devices. If satisfied that the relevant product conforms
to the relevant essential requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for
its own declaration of conformity. The manufacturer may then apply the CE mark to the device, which allows the device to be placed on
the market throughout the EU. If we fail to comply with applicable EU laws and regulations, and corresponding EU member state laws, we
would be unable 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 EEA, which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland. Non-compliance with
the above requirements would also prevent us from selling our products in these three countries.

Federal, State and Foreign Fraud