Accidents, Field Safety Corrective Actions and Safety Alerts: The Medical Device Vigilance System. The main purpose of the surveillance system is to increase the safety profile of medical devices (DM) and to improve the protection of the health of users.
According to Article 10 of Regulation (EU) 745/2017, it is the obligation of manufacturers to establish, document, apply, maintain, update and constantly improve a quality management system that guarantees compliance in the most effective and proportionate way. the risk class and type of device.
The quality management system covers various aspects and in particular the processes for reporting serious incidents and safety corrective actions in the context of supervision.Article 2 of the MDR provides the definitions of accident and serious incident, of Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN). In fact, these are key elements of supervisory management to which Articles 87, 88, 89 and 90 are entirely dedicated.
A proactive (post-marketing surveillance) and reactive (surveillance) approach in the management of everything related to the experience gained on the devices on the market is essential in pursuing the safety objectives of these products.
Manufacturers must report to the relevant competent authorities
any serious incident relating to devices made available on the Union market, except for the expected side effects which are clearly documented in the product information and quantified in the technical documentation and which are the subject of trend reports;
any safety corrective action relating to devices made available on the Union market.
Following the report of the serious accident, the timing of which is commensurate with the seriousness of the accident, the manufacturer carries out the necessary investigations:
This includes a risk assessment and corrective safety actions.
Member States shall take the necessary measures to ensure that the information relating to the accident that has occurred or the corrective safety action undertaken or planned is centrally assessed, at national level, by their competent authority (AC), where possible together with the manufacturer.
In the context of the assessment, the A.C. evaluates the risks deriving from the serious accident reported and any related corrective safety actions, taking into account the protection of public health and criteria such as:
- the causes, the individuality and probability of recurrence of the problem, the frequency of use of the device , the likelihood of direct or indirect harm and its severity, the clinical benefit of the device, the intended and potential users and the affected population.
- The competent authority also assesses the adequacy of the safety corrective action as well as the need and nature of any other corrective action.