請TE驗證

請TE驗證

結果 (英文) 1:

Please TE verify

結果 (英文) 2:

Chapter III - Origin and Traceability of devices, contentof devices and of economics, summary of safety and clinical performance, data Europeanbank on medical devices.
The EU will will will force of the new version of the European databank on the medical devices (EUDAMED) currently under construction for traceability, registration of devices and publication of of the Information concerning medical devices on the EU market. The database will will be accessible to the first time, end users and the general public will have to have the right to the information in EUDAMED. Manufacturers will will need to prepare for and implement Unique Devices (UDIs) for all of its devices, although UDI will will be implemented in
Phases on the risk classs of the products, yn ly leading to all devices requiring a UDI.
Manufacturers will need to to provide a lysy and clinical performance for class III devices and also for implants of the lower classification, who will be a good. This summary must-must-do include-other-things the le-in of the device, the olys and contra-ins, the reference to the standards and CS, a summary of of the
clinical evaluations and suggested profile and training of users. ...

結果 (英文) 3:

Please verify TE.