Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 17

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 17
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 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.

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. Except for low-risk medical devices (Class I non-sterile, non-measuring devices),
where the manufacturer can self-assess 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 a notified
body. 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 general safety and performance 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.

In the EU, devices lawfully
placed on the market pursuant to the EU Medical Devices Directive prior to May 26, 2021 may generally continue to be made available on
the market or put into service, provided that the requirements of the transitional provisions are fulfilled. In particular, no substantial
change must be made to the device as such a modification would trigger the obligation