Kliininen evaluointi – suorituskyvyn arviointi
Suorituskyvyn arviointi on vaatimus in vitro-diagnostiikkaan tarkoitettuja lääkinnällisiä laitteita koskevassa asetuksessa (2017/746).
Performance evaluation is a requirement in the In-vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
It refers to an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device.
Before any in vitro diagnostic medical device can be legally placed on the EU market, a manufacturer must comply with the requirements of the IVD Regulation.
Clinical evidence shall support the intended use of the device and be based on a continuous process of performance evaluation.
Performance evaluation shall demonstrate the scientific validity, analytical performance and clinical performance of the device and it shall follow a performance evaluation plan.
The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance that the relevant safety and performance requirements of the IVD Regulation are fulfilled.
How can Labquality help?
Labquality helps manufacturers comply with the clinical evidence requirements of the IVD Regulation by:
✔ making the performance evaluation plan
✔ making plans and reports for analytical performance studies
✔ demonstrating the scientific validity through a systematic literature review
✔ making plans and reports for clinical performance studies
✔ making the performance evaluation report
Labquality provides medical device manufacturers with clinical evaluation services that will help them comply with MDR regulations.
The Medical Devices Regulation 2017/745 requires that the demonstration of conformity with the General Safety
and Performance Requirements must include a clinical evaluation.
Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse, and assess the clinical data pertaining to a device to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
The level of clinical evidence and the depth of the clinical evaluation required to ensure both the safety and performance of the medical device shall be proportionate to the risk class of the device, as well as its characteristics and intended purpose.
How can Labquality help?
Labquality can help medical device manufacturers comply with the clinical performance requirements of MDR by
✔ Writing the clinical evaluation plan, including the definition of the state of the art
✔ Performing a systematic literature review relating to the safety, performance, design characteristics, and intended purpose of the device
✔ Evaluating the need for clinical investigation
✔ Helping with the clinical investigation documents if needed
✔ Writing a clinical evaluation report
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Kliininen tutkimus on järjestelmällinen kokonaisuus lääkinnällistä laitetta koskevien kliinisten tietojen jatkuvaa tuottamista ja arviointia varten.