Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 170

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 170
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 restrictions or partial suspension or total shutdown of production;                    
  refusing or delaying requests for marketing authorization of new products or modified products;  
  withdrawing marketing authorizations that have already been granted;                             
  refusal to grant export approvals for; or                                                        
  criminal prosecution.                                                                            

Regulation of Medical Devices in the European
Union

In the European Union, or
EU, until May 25, 2021, medical devices were regulated by the Council Directive 93/42/EEC, or the EU Medical Devices Directive, which
has been repealed and replaced by Regulation (EU) No 2017/745, or the EU Medical Devices Regulation. Unlike directives, regulations are
directly applicable in all EU member states without the need for member states to implement into national law.

In the EU, there is currently
no premarket government review of medical devices. However, all medical devices placed on the EU market must meet general safety and performance
requirements, 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.

Compliance with the general
safety and performance requirements is a prerequisite for European conformity marking, or CE mark, without which medical devices cannot
be marketed or sold in the EU. To demonstrate compliance with the general safety and performance requirements medical device manufacturers
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), 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. Notified bodies are independent organizations designated by EU member states to assess the
conformity of devices before being placed on the market. A notified body would typically audit and examine a product’s technical
dossiers and the manufacturer’s quality system. If satisfied that the relevant product conforms to the relevant general safety and