Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 18

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 18
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 to obtain a new certification under the EU Medical
Devices Regulation and therefore to have a notified body conducting a new conformity assessment of the devices. Once our devices are certified
under the EU Medical Devices Regulation, we must inform the notified body that carried out the conformity assessment of the devices that
we market or sell in the EU and EEA of any planned substantial changes to our quality system or substantial changes to our medical devices
that could affect compliance with the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation
or cause a substantial change to the intended use for which the device has been CE marked. The notified body will then assess the planned
changes and verify whether they affect the products’ ongoing conformity with the EU Medical Devices Regulation. If the assessment
is favorable, the notified body will issue a new certificate of conformity or an addendum to the existing certificate attesting compliance
with the general safety and performance requirements and quality system requirements laid down in the Annexes to the EU Medical Devices
Regulation. The notified body may disagree with our proposed changes and product introductions or modifications could be delayed or canceled,
which could adversely affect our ability to grow our business.

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.

From January 1, 2021 onwards,
the Medicines and Healthcare products Regulatory Agency, or MHRA became the sovereign regulatory authority responsible for the Great Britain
(i. e. England, Wales and Scotland) medical device market according to the requirements provided in the Medical Devices Regulations 2002
(SI 2002 No 618, as amended), or UK Medical Devices Regulations, that sought to give effect to the three pre-existing EU directives governing
active implantable medical devices, general medical devices and in vitro diagnostic medical devices whereas Northern Ireland continues
to be governed by EU rules according to the Northern Ireland Protocol. Following the end of the Brexit transition period on January 1,
2021, new regulations require all medical devices to be registered with the MHRA before being placed on the Great Britain market. The
MHRA will only register devices where the manufacturer or their United Kingdom, or UK, Responsible Person has a registered place of business
in the UK. Manufacturers based outside the UK must appoint a UK Responsible Person that has a registered place of business in the UK to
register devices