Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 19

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 19
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 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. In addition, the MHRA launched
a consultation between November 14, 2024 and January 5, 2025 on proposals to update the pre-market requirements for medical devices in
Great Britain. The MHRA has stated that it will incorporate feedback to this consultation into new UK legislation on pre-market requirements
for medical devices in Great Britain. The new legislation is expected to come into force in 2026. Under the UK Medical Devices Regulations,
in order to be lawfully placed on the Great Britain market, class I (non-sterile, non-measuring or non-re-useable) medical devices need
to be “ UKCA” self-certified, and other medical devices need to be “ UKCA” certified by a UK approved body. However,
certain medical devices in compliance with: (1) the EU Medical Devices Directive can continue to be placed on the Great Britain market
until the sooner of certificate expiration or June 30, 2028; or (2) the EU Medical Devices Regulation can continue to be placed on the
Great Britain market until the sooner of certificate expiration or June 30, 2030. Medical devices also need to bear a physical United
Kingdom Conformity Assessment, or UKCA, mark in order to be lawfully placed on the Great Britain market. However, one of the key topics
in the MHRA’s recent consultation was to obtain feedback on whether to remove the requirement for a medical device and its labelling
(i. e. packaging and instructions for use) in Great Britain to bear a physical UKCA mark. Instead of requiring a medical device and its
labelling to bear a UKCA mark, manufacturers would be required to assign a unique design identification, or UDI, to medical devices before
they are placed on the Great Britain market. If our devices were approved for marketing in the UK and this change would be implemented,
we would no longer be required to affix the physical UKCA mark to our devices, but we might need to assign and affix a UDI. Understanding
and ensuring compliance with any new requirements is likely to lead to further complexity and increased costs to our business. If there
is insufficient UK approved body capacity, there