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Homepage Pharmaceutical Industry Medical devices Vigilance Reporting – Medical Devices Serious Incident Reporting

Serious Incident Reporting

A “Serious Incident” as defined in Article 2, point 65 of the MDR and Article 2, point 68 of the IVDR means an incident that directly or indirectly leads, might have led, or might lead to any of the following consequences:

  • Death of a patient, user, or other person
  • Temporary or permanent serious deterioration of a patient’s, user’s, or other person’s state of health
  • Serious public health threat

According to Article 87(1)(a) of the MDR or Article 82(1)(a) of the IVDR, manufacturers must report each serious incident to the competent authorities, in accordance with Article 92(5) of the MDR or Article 87(5) of the IVDR, through the electronic system (hereinafter referred to as the “Eudamed database”) mentioned in Article 92 of the MDR or Article 87 of the IVDR.

Until the Eudamed database is fully functional according to Article 34 of the MDR, the procedures established in accordance with the relevant provisions of Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices shall apply for the purposes of fulfilling obligations involving the exchange of information relating to vigilance reports, in accordance with the transitional provision of Article 123(3)(d) of the MDR and Article 113(3)(f) of the IVDR.

Preliminary Incomplete Reporting If it is necessary to ensure timely reporting of a serious incident, in accordance with Article 87(6) of the MDR or Article 82(6) of the IVDR, the manufacturer is entitled to send a preliminary incomplete report to the Institute, followed by a complete report.

Deadlines for Reporting Serious Incidents the time limits for submitting reports depend on the severity of the serious incident:

  • Immediately, but no later than 2 days after the manufacturer becomes aware of a serious public health threat
  • Immediately, but no later than 10 days after the manufacturer becomes aware of a serious incident – in the case of death or an unexpected serious deterioration in a person’s state of health
  • Immediately, but no later than 15 days after the manufacturer becomes aware of the serious incident

If the manufacturer has doubts about whether an adverse event should be reported, they should still submit a report within the specified time limit (Article 87(7) MDR or Article 82(7) IVDR).

Pursuant to Art. 87(1)(a) of the MDR, serious incidents shall be reported by manufacturers to the Institute by means of an electronically completed serious incident report form  signed with a recognised electronic signature in compliance with the guidance provided by the European Commission on the vigilance system.

Forms shall be sent to SÚKL in the PDF format along with the completed data file in the XML format by means of:

 Should you report a serious incident or suspected serious incident of a medical device outside working hours, i.e. Mon-Fri 8.00 AM -04.30 PM or during Saturdays, Sundays, and public holidays, please sent the respective forms to the e-mail address of the Institute’s 7/24 service at urgent@sukl.gov.cz. Should you have any doubts or issues concerning the correct course of action to be taken, please ask for assistance at +420 272 185 999.

  • Initial incomplete report and final report

Where necessary to ensure timely reporting of a serious incident as referred to under Art. 87(6) of the MDR, the manufacturer may submit to the Institute an initial report that is incomplete followed up by a complete report.

The final report referred to under Art. 89(5) of the MDR shall be submitted by the manufacturer to the Institute electronically, by means of a completed serious incident report form signed with a recognised electronic signature, if the incident meets the reporting criteria (reportable incident). If the incident was classified as non-reportable, the manufacturer shall use the Final report (non-reportable incident) form to submit the outcome of the incident investigation.

Forms shall be submitted to the Institute in a manner analogous to other reports, i.e., in the PDF format along with the completed data file in the XML format, either via the web interface or by means of a data message or electronic mail.