Team Lead, Quality and Regulatory Affairs
Performance evaluation is a requirement in the In vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
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.
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
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
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.
A clinical evaluation must follow a defined and methodologically sound procedure and it shall follow a clinical evaluation plan. A clinical evaluation shall be thorough and objective and consider both favourable and unfavourable data.
This is achieved by identifying, appraising, and analysing all available and relevant clinical data:
✔ The relevant scientific literature currently available ✔ The results of all available clinical investigations
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
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