To CE-mark a medical device the manufacturer needs to provide clinical evidence of safety and performance and is needed for all medical devices, irrespective of device class or legislation (MDR or IVDR). The manufacturer must during the whole life-cycle of the device, evaluate whether there is still sufficient clinical evidence to support that the device can be safely used and regarded as state-of-the-art technology.
A fundamental initial step is to have an adequate clinical strategy to drive the whole process forward. Clinical evidence for a medical device is generally based on clinical data, i.e. results from the clinical use of the device or an equivalent device. Clinical data are summarised and analysed in the clinical evaluation.
For IVD-devices, clinical evidence also includes the results of the performance evaluation, including scientific validity, analytical performance and clinical performance.
QAdvis can provide knowledge on standards of relevance for clinical studyies and align the clinical strategy with US FDA requirements to minimise any duplicated work later on.
Example of support:
- ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice
- ISO 20916 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
- Develop an over-all clinical strategy in line with MDR and/or IVDR
- Identify any gaps in clinical data aiming at demonstration of clinical evidence for a device
- Perform clinical evaluations according to the MDR
- Contribute to performance evaluation according to the IVDR, including planning of clinical performance studies
- Perform literature reviews to form part of clinical evaluation / performance evaluation
- Write clinical evaluation, summary of safety and performance and summary of safety and clinical performance
- Review clinical evaluation / performance evaluation documentation
- Review or develop procedures for clinical evaluation / performance evaluation
- Assist in resolving non-conformities
- Provide training (customized or in open class)