Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 391

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 391
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 comply with the EU medical device vigilance system. Under this system, serious incidents and Field Safety Corrective Actions (“FSCAs”) must be reported to the relevant authorities of the EU member states. These reports will have to be submitted through Eudamed — once functional — and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states, other actors such as the economic operators in the supply chain will also be informed. Until Eudamed is fully functional, serious incidents and ESCAs are reported directly to the relevant authorities of the EU member states. A serious incident is defined as any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use- error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect, which, directly or indirectly, might have led or might lead to the death of a patient or user or of other persons or to a temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health or a serious public health threat. Manufacturers are required to undertake 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. FSCAs must be reported to the relevant authorities of the EU member states and communicated by the manufacturer or its legal representative to its customers and/or to the end users of the device through Field Safety Notices.

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For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a FSCA implemented or where the incidents are common and well documented, manufacturers may provide periodic summary reports instead of individual serious incident reports.

The EU Medical Devices Regulation generally requires that manufacturers provide clinical data providing sufficient clinical evidence to demonstrate conformity with relevant general safety and performance requirements set out in Annex I. The level of clinical evidence must be appropriate in view of the characteristics of the device and its intended purpose. For certain high-risk devices, including Class III implantable devices, the devices may be required to undergo a clinical evaluation consultation as part of the conformity assessment. The EU Medical Devices Regulation includes provisions on the conduct of

clinical investigations, which are defined as any systematic investigations involving one or more human subjects, undertaken to assess the safety or performance of a device. Once functional, sponsors