Reactovigilance: monitoring and safety of medical devices by the ANSM

Introduction

Reactovigilance is an essential pillar of health safety in France. This surveillance focuses on incidents and risks of incidents resulting from the use of an in vitro diagnostic medical device (IVDMD).

Definition and regulatory framework of reactovigilance

What is reactovigilance?

Reactovigilance is the monitoring of incidents and risks of incidents resulting from the use of an in vitro diagnostic medical device (IVDMD). This monitoring enables health authorities to quickly identify potential problems and take appropriate corrective measures.

Devices subject to surveillance

Reactovigilance applies to all IVDMDs, including medical biology reagents, standards and controls, medical biology analysis machines, including their software, self-diagnostic devices, and pathological anatomy and cytology devices.

IVDR Regulation and European developments

May 26, 2022 marked an important milestone in the transition to the new requirements set by the EU In Vitro Diagnostic Medical Devices Regulation (IVDR). The IVDR—In Vitro Diagnostic Regulation—is the new European Regulation 2017/746 on in vitro diagnostic medical devices (IVDs), which came into force in May 2022. These reference texts harmonize European practices in terms of surveillance.

Actors and responsibilities in medical device vigilance and reagent vigilance

Manufacturers and distributors

Manufacturers play a central role in the pharmacovigilance system. They are required to report any incidents of which they are aware and to take the necessary corrective measures. Distributors must also participate in reporting and cooperate with health authorities.

Local reactor safety correspondent (CLRV)

The CLRV is a doctor or pharmacist with experience in DMDIV. The appointment of a CLRV is mandatory in all relevant healthcare facilities. They perform several essential tasks: processing safety notices, training and raising awareness among teams, and liaising with regional and national authorities.

Patient safety reporting process

Events that must be reported

All incidents related to the use of IVDMDs must be reported: technical malfunctions, erroneous results with clinical consequences, reagent quality defects, analysis software problems, incidents related to packaging or labeling.

Available reporting portals

Since 2017, an online portal for reporting adverse health events, signalement.social-sante.gouv.fr, has been set up by the Ministry of Health, in partnership with health agencies, and in particular the ANSM (French National Agency for Medicines and Health Products Safety).

To strengthen vigilance in health safety and simplify reporting procedures, the new portal signalement-sante.gouv.fr allows professionals and users to report any adverse events to the health authorities in just a few clicks.

Regulatory notification deadlines

Reports concerning serious cases must be sent to the ANSM without delay, i.e. as soon as possible after gathering the essential information needed to deal with the incident. Healthcare professionals must immediately notify the local reactovigilance correspondent (CLRV) of any incidents of which they are aware.

Role of the ANSM in health monitoring

National coordination mission

The ANSM oversees the national pharmacovigilance system and coordinates actions with the various stakeholders: regional coordinators, local correspondents, manufacturers, and healthcare professionals. This management of reports enables the agency to analyze the reports received and take the necessary safety measures.

Safety measures and corrective actions

The ANSM may take health policy measures such as suspending manufacturing, importation, or marketing; prohibiting activities that have led to incidents; and applying restrictions or specific conditions on the use of medical devices.

Conclusion

Reactovigilance is an essential link in the French healthcare safety chain. By enabling early detection of malfunctions and rapid response by the relevant authorities and organizations, this system effectively protects patients and continuously improves the quality of medical diagnoses.

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