Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 172

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 172
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 act swiftly when needed to address safety issues and support the entire
health system in better protecting patients. 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, covering four topics, namely: (1) a new international
reliance scheme to enable swifter market access for certain devices that have already been approved in a comparable regulator country;
(2) the new UKCA mark and, in particular, proposals to remove the requirement to place such UKCA marking on devices; (3) conformity assessment
procedures for in vitro diagnostic devices; and (4) maintaining in UK law certain pieces of “assimilated” EU law which are
due to sunset in 2025. This consultation builds on the MHRA’s previous consultation between September and November 2021, and the
UK government’s response to that consultation which was published on June 26, 2022. The MHRA has stated that it will incorporate
feedback to its recent consultation into new legislation on pre-market requirements for medical devices in Great Britain. The new legislation
is expected to be implemented in 2026 and aims to enable greater international collaboration and practices, with more patient-centered,
proportionate requirements for medical devices which are responsive to technological advances.

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.

In addition, the trade deal
between the UK and the EU generally provides for cooperation and exchange of information between the parties in the areas of product safety
and compliance, including market surveillance, enforcement activities and measures, standardization-related activities, exchanges of officials,
and coordinated product recalls. As such, processes for compliance and reporting should reflect requirements from regulatory authorities.

Under the terms of the Northern
Ireland