Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 390

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 390
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 who is ultimately responsible for key aspects of compliance 
 with the requirements of the new Regulation;                                                                                         |

| ● | improves                                                                                                                                       
 the traceability of medical devices throughout the supply chain to the end-user or patient through the introduction of a unique identification 
 number, to increase the ability of manufacturers and regulatory authorities to trace specific devices through the supply chain and             
 to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk;                                |

| ● | sets                                                                                                                                    
 up a central database (Eudamed) to provide patients, healthcare professionals and the public with comprehensive information on products 
 available in the EU; and                                                                                                                |

| ● | strengthens                                                                                                                           
 rules for the assessment of certain high-risk devices, such as implants, which may have to undergo a clinical evaluation consultation 
 procedure by experts before they are placed on the market.                                                                            |

The EU Medical Devices Regulation requires that before placing a device, other than a custom-made device, on the market, manufacturers (as well as other economic operators such as authorized representatives and importers) must be registered in the electronic system (Eudamed). The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons responsible for regulatory compliance. The new Regulation also requires that before placing a device, other than a custom-made device, on the market, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database. These new requirements aim at ensuring better identification and traceability of the devices. Each device — and as applicable, each package — will have a UDI composed of two parts: a device identifier (“UDI-DI”) specific to a device, and a production identifier (“UDI-PI”) to identify the unit producing the device. Manufacturers are also notably responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to date. The obligations for registration in Eudamed will become applicable at a later date (as Eudamed is not yet fully functional). Until Eudamed is fully functional, which is currently planned for 2027 according to the European Commission, the corresponding provisions of the EU Medical Devices Directives continue to apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in particular, information regarding registration of devices and economic operators.

All manufacturers placing medical devices on the market in the EU must