Clinical evaluation and clinical investigations
Clinical evaluation of medical devices
Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device. Clinical data is sourced from clinical investigations, scientific literature and clinical follow-up of the device concerned or from a device for which equivalence to the device in question can be demonstrated. The clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
According to the EU Medical Devices Regulation (EU) 2017/745, manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in the EU Regulation, including post-market clinical follow-up. Clinical evaluation is thus mandatory for all products.
The manufacturer shall specify the intended purpose of the product, which shall be specified in the clinical evaluation.
Manufacturers shall perform clinical evaluation in accordance with the requirements set out in Article 61 and Part A of Annex XIV, including post-market clinical follow-up.
The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer's post-market clinical follow-up plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.
More information on clinical studies on medical devices can be found via page: Clinical investigations of devices
Performance evaluation of IVD-devices
Performance evaluation of IVD medical devices shall follow a defined and methodologically sound procedure for the demonstration of the scientific validity, analytical performance and clinical performance the device. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.
A performance evaluation should follow a defined and methodologically sound procedure for the demonstration of scientific validity, analytical performance and clinical performance, as stated in the Article 56 and Part A of Annex XIII of IVDR ((EU) 2017/746). The performance evaluation and its documentation shall be updated throughout the life cycle of the device.
More information on performance studies of IVD-devices can be found via page: Performance studies of IVD-devices