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Incidents, safety corrective actions and safety warnings: the vigilance system of medical devices.

The main scope of the vigilance system is to increase the safety profile of medical devices (MDs) and to improve the users’ health protection.

According to article 10 of Regulation (EU) 745/2017, it is mandatory for manufacturers to establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

The quality management system concerns different aspects, especially the processes to report serious incidents and safety corrective actions in the contexts of pharmacovigilance.

Article 2 of the MDR provides the definitions of incident and serious incident, safety corrective action (FSCA, Field Safety Corrective Action) and safety notice (FSN, Field Safety Notice). Articles 87, 88, 89 and 90 are wholly dedicated to these key elements in the vigilance management.

A pro-active (post-market surveillance) and reactive (vigilance) approach in the management of anything concerning the experience acquired on the devices on the market is essential to pursue safety scopes for these products.

Manufacturers should report the following to the relevant competent authorities:

  • any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting;
  • any field safety corrective action in respect of devices made available on the Union market.

Following a serious incident report, whose timetable is commensurate with the severity of the incident, the manufacturer shall carry out the necessary investigations: these include a risk assessment and any field safety corrective measure.

Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred, or a field safety corrective action that has been undertaken or envisaged is evaluated centrally at national level by their competent authority (CA), if possible together with the manufacturer.

In the context of the evaluation, the CA shall evaluate the risks arising from the reported serious incident and any related field safety corrective actions, taking into account the protection of public health and criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of direct or indirect harm and its severity, the clinical benefit of the device, intended and potential users, and population affected. The authority shall also evaluate the adequacy of the field safety corrective action as well as the need for, and kind of, any other corrective action.

The manufacturer has the responsibility to ensure that information about the FSCA taken is brought to the attention of users of the device in question by means of a field safety notice.

The FSN shall be published in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. The content of the field safety notice shall be consistent in all Member States, except in special cases: it shall explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons, clearly indicating all the actions to be taken by users.

The switch from Directive 93/42/EEC as amended (MDD) to Regulation (EU) 2017/745 as amended (MDR) changed the method of transmission of the field safety notice to the competent authority: according to the MDD the manufacturer must include copy of the FNS in the notification to the national Competent Authority and all CAs of the concerned countries, whereas in the MDR the manufacturer shall enter it in the electronic system through which that notice shall be accessible to the public. However, the provisions of the Directive will apply until Eudamed is fully operative.

The field safety notice is therefore essential because it represents a bridge between the manufacturer and the users, for the protection of their health, allowing an appropriate identification of the concerned device(s) and of the manufacturer that undertook the safety corrective measure.

Written by: Ilaria Perretti