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1. The following considerations should be taken into account when conducting a clinical evaluation
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- Class III and Class IIb products shall carry out clinical investigations.
- Class III and Class IIb devices are subject to inclusion of clinical evaluation user manuals and PMCF plans.
- Manufacturers require expert consultation on clinical evaluation and clinical research.
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2. Procedure for obtaining clinical data is as follows.
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- Data collection on clinical experience of equivalent medical devices.
- Deriving clinical results through clinical research reports.
- Clinical investigation using similar devices.
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3. Clinical assessment should follow one of the following procedures.
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- Evaluation of scientific literature that assesses design characteristics, stability, and performance of medical devices as they demonstrate equivalence with relevant devices and comply with requirements.
- Clinical Evaluation considering alternative treatments currently used.
The clinical evaluation shall be updated with the validity period of the medical device, with clinical data carried out under the PMCF plan referred to in Annex XV Part B and 84 of MDR. For CLASS III and CLASS IIB implantable devices, the PMCF report shall be updated annually, and a summary of the safety and performance of medical devices will be uploaded to the EUDAMED and updated annually.
