Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 393

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 393
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Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the United States, on medical device manufacturers. Certain countries also mandate implementation of commercial compliance programs.

The aforementioned EU rules are generally applicable in the EEA, which consists of the 27 EU Member States plus Norway, Liechtenstein and Iceland.

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United Kingdom

In the United Kingdom (“UK”), the medical devices market is regulated by the Medicines and Healthcare products Regulatory Agency (“MHRA”), which performs market surveillance of medical devices on the UK market. Devices are regulated under the Medical Devices Regulations 2002 (“MDR 2002”), which gave effect in UK law to the following EU directives: Directive 90/385/EEC on active implantable medical device; new UK Medical Devices Regulations that will substantially amend the MDR 2002 are expected to come into force on July 1, 2024. Directive 93/42/EEC on medical devices; and Directive 98/79/EC on in vitro diagnostic medical devices.

The UK Conformity Assessed (“UKCA”) marking is a UK product marking used for medical devices being placed on the Great Britain market. It is not recognized in the EU, so these products require a CE marking as well. CE marketed devices will be accepted on the Great Britain market until June 30, 2024. From July 1, 2024, devices placed on the Great Britain market will need to conform to UKCA marketing requirements. Manufacturers based outside the UK wishing to place a device on the UK market, need to establish a UK Responsible Person for the product in the UK. Regarding medical devices placed on the Northern Ireland (“NI”) market, these must comply with the applicable EU legislation in conformity with the Northern Ireland Protocol. As such medical devices placed on the NI market must continue to be CE marked. The UK Government recently reached a new political agreement with the EU, the “Windsor Framework” which may lead to changes to the NI Protocol in the future.

We may need to support clinical and/or regulatory requirements in the UK for our LBI-201 Aureva TMPulse product candidate, and potentially others.