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Vigilance

Incidents with medical devices in the Republic of Latvia are managed in medical device vigilance system following the requirements prescribed in the Regulation No. 689 of the Cabinet of Ministers of the Republic of Latvia "Procedure for Registration, Assessment, Distribution, Exploitation and Technical Supervision of Medical Devices" adopted on 28 November 2017.

The purpose of the vigilance system is to ensure the possibility for the Member States to identify concurrently the model and series of non-conforming medical device in the circulation and use and prevent recurrence of incidents via use of the incident notification system of the users of medical devices in all European Union Member States.

According to the Regulation No.689 a user of the medical device together with the owner or holder thereof shall, within three days after the incident, send a signal report to the manufacturer or the authorized representative of the manufacturer and distributor of the medical device, as well as to the State Agency of Medicines. The State Agency of Medicines shall follow the investigation procedure of the incident.

A manufacturer of a medical device shall be fully liable for the implementation of the necessary investigation operations in case of the incident regardless of the place of detection and investigation of the incident, ensuring the time record schedule from the time of the notification of the manufacturer. An initial report of the manufacturer regarding the incident with the medical device shall be sent to the State Agency of Medicines of Latvia within 10 days. A report of the manufacturer regarding a potential incident with the medical device shall be sent to the State Agency of Medicines not later than within 30 days.

A manufacturer shall, after finishing the investigation, draw up and transfer to the Agency the final report of the investigation. The final report of the investigation of the incident shall be a notification regarding the results obtained and the necessary operations coordinated.

A manufacturer shall ascertain that the procedures referred to in Chapter 12 of the Regulation No.689 are applied by the authorized representatives or other persons who are jointly responsible for placing the medical device on the market, maintenance of it and use of the vigilance system procedure.

If the investigation process confirms the necessity for corrective actions, the State Agency of Medicines of Latvia shall inform the competent authorities of other European Union Member States and the European Commission.

 

Report form Manufacturer's Incident Report

 

Report form Field Safety Corrective Action (FSCA)