Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 142

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 142
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 and state governments will pay for health care products and services, which could result
in reduced demand for our products or additional pricing pressure.

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European Union Regulation

In
order to sell our products in member states of the EU, our products must comply with the general safety and performance requirements of
the EU Medical Devices Regulation, or Regulation (EU) No 2017/745), which repeals and replaces the EU Medical Devices Directive (Council
Directive 93/42/EEC) and the Active Implantable Medical Devices Directive (Council Directive 90/385/EEC).

Compliance
with these requirements is a prerequisite to be able to affix the European Conformity, or CE, mark to our products, without which they
cannot be sold or marketed in the EU. All medical devices placed on the market in the EU must meet the general safety and performance
requirements laid down in Annex I to the EU Medical Devices Regulation including the requirement that a medical device must be designed
and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose. Medical devices must be
safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and –
where applicable – other persons, provided that any risks which may be associated with their use constitute acceptable risks when
weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account
the generally acknowledged state of the art. The European Commission has adopted various standards applicable to medical devices. These
include standards governing common requirements, such as sterilization and safety of medical electrical equipment and product standards
for certain types of medical devices. 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