Clinical evaluations of medical device and in-vitro diagnostics
Medical devices generally cannot be marketed without clinical data and an analysis of these data. In the case of class III medical devices and implantable devices, there is also the requirement to conduct clinical trials and to analyse the resultant clinical data for medical performance.
The clinical evaluation must be undertaken on the basis of a defined and methodologically faultless procedure and take account of any relevant harmonised standards.
The clinical evaluation is intended
- to show that under normal conditions of use the device achieves the medical performance specified by the manufacturer
- to determine whether adverse effects occur
- to assess whether the adverse effects are justifiable relative to the performance delivered
- to assess whether the risk/benefit ratio is acceptable
The clinical evaluation is usually carried out on the basis of clinical data. Clinical data are obtained from completed and uncompleted clinical trials. They can also be based on scientific literature, earlier clinical trials or clinical trials supplemented by literature data. If the clinical data are based on the literature, even in combination with data from clinical investigations, the manufacturer must justify this procedure and demonstrate equivalence with the medical device concerned, particularly in terms of safety, performance, design characteristics and intended purpose. orangeglobal helps you to carry out the clinical evaluations and investigations necessary for the registration of your medical devices as well as performance evaluations for in-vitro diagnostics.
Read More: Clinical evaluation between EU Directives (MDD, AIMDD) and EU Regulation (MDR)