A medical device may only be placed on the market after the CE marking procedure has been implemented.
The crucial marking step is carried out by means of risk analysis.
This is done with the aim of ensuring that the device is safe and meets the requirements of its intended use.
In short, the aim is to establish, through risk assessment, the hazards and risks that may arise and the consequent mitigation actions that make the risk acceptable.
In order to carry out risk assessment and the definition of mitigation actions, the following activities have been performed for each group of homogeneous devices: 1. constitution of files:
1.1. production technician: concerns the analysis of the device from a technical production point of view.
The following phases are analysed: commercial, design, manufacture and control. In addition, validation actions (processes) and support actions (human resources, material and measurement resources) are defined;
1.2. clinical investigation: concerns the analysis of the device from a clinical point of view in relation to its use. Validation of the use of the device and the manufacturing and control actions are analysed. These must be carried out in such a way that the device is clinically safe. This file is self-supported and does not refer to other files as it is normally analysed by a clinician;
1.3. packaging and labelling: in relation to the distribution and end-user supply chain, the packaging and subsequent labelling is established.
The aim is for the residual risk which cannot be eliminated (but is still acceptable) to be managed (outside the manufacturing process) in such a way that it always remains at an acceptable level throughout the distribution chain until its end use.
2. after-sales surveillance and clinical follow-up:
2.1 after-sales surveillance (PSUR – PMS): for the specific device, surveillance of the product (manufacturer and competing manufacturers) and on the reference market is organised and carried out (with the necessary frequency – in relation to the residual risk).
This from the technical and suitability for use viewpoint;
2.2. clinical follow-up (PMCF): clinical surveillance of the product is organised and carried out for the same device.
The results of the analyses, of both assessments, must be incorporated in order to keep manufacturing risks (quality systems 9001 and 13485) and the management of residual risks that cannot be eliminated under control.
The activities are developed, through ad hoc procedures, taking into account the legislation and regulations in force (regulation 745, MEDDEV, standard 14971 etc.).