Clinical evaluations follow a defined and methodological procedure (Guide MEDDEV 2.7.1 Rev 4 guide) based on:
- A critical evaluation of the relevant scientific publications currently available for an equivalent device in terms of safety, performance, design features, and end use of the device, provided that:
- The equivalence of the device that is the subject of the clinical evaluation in terms of the end use, and the device to which the data refers is demonstrated, and
- Compliance with relevant general requirements relating to safety and performance is duly established;
- A critical evaluation of the results of all the clinical investigations available on the device
- The taking into account of alternative procedures currently available for this purpose if there are any.
The clinical evaluation and associated documentation are updated throughout the life cycle of the device concerned with clinical data obtained by the manufacturer following the application of its PMCF (Post-Market Clinical Follow-up) and its post-market surveillance plan.
Manufacturers of class IIa, IIb, and III devices must establish, for each device, and if necessary for each category or group of devices, a Periodic Safety Update Report (PSUR) summarising the results and conclusions of the analysis of the post-market surveillance data that has been collected in the frame of the post-market surveillance plan that presents the justification of any preventive or corrective measure taken and describes them.