Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 171

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 171
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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.

Throughout the term of the
certificate of conformity, the manufacturer will be subject to periodic surveillance audits to verify continued compliance with the applicable
requirements. In particular, there will be a new audit by the notified body before it will renew the relevant certificate(s).

All manufacturers placing
medical devices into the market in the EU must comply with the EU medical device vigilance system. Under this system, serious incidents
and Field Safety Corrective Actions, or FSCAs, must be reported to the relevant authorities of the EU member states. Manufacturers are
required to take FSCAs defined as any corrective action for technical or medical reasons to prevent or reduce a risk of a serious incident
associated with the use of a medical device that is made available on the market. An FSCA may include the recall, modification, exchange,
destruction or retrofitting of the device.

The aforementioned EU rules
are generally applicable in the European Economic Area, or EEA, which consists of the 27 EU member states plus Norway, Liechtenstein and
Iceland.

Brexit

Since January 1, 2021, the
MHRA has become 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 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. Manufacturers based outside the UK need to appoint a UK responsible person that has a registered place of business in the UK to
register devices with the MHRA.

Furthermore, on December 16,
2024, the UK government published an amendment to the UK  Medical Devices Regulations to clarify and strengthen the post-market surveillance
requirements for medical devices in Great Britain. This amendment will come into force on June 16, 2025, and aims to facilitate greater
traceability of incidents and trends enabling the MHRA to