Last 11th October, the Italian Ministry of Health issued the document “Vigilanza sugli incidenti con i Dispositivi Medici” which provides specifics about the operational instructions on modalities and timing of Medical Devices’ Manufacturers’ reports, addressed to Economic Operators involved in serious and non-serious accidents as well as complaints after such Medical Devices have been placed on the market, in particular in relation to Article 10 of Legislative Decree 5th August 2022, No.137, in force since 28 September last.

In particular, in the event of an accident, the Manufacturer is obliged to:

  • Acquire all necessary information relating to the accident;
  • Report the accident to the competent Authority using the Manufacturer Incident Report form MIR 7.2.1:
  • Within 15 days in case of serious accidents;
  • Within 2 days in case of a serious threat to public health;
  • Within 10 days in case of death or unexpected serious deterioration of a person’s health;

NB: the Manufacturer may also submit Periodic Summary Reports (PSRs) instead of individual reports in the case of similar serious accidents occurring with the same device or same device type and for which the root cause has been identified; in this case the Manufacturer’s Periodic Summary Report template contained in Meddev 2.12-1 Rev.8 should be used.

In the case of non-serious accidents or unexpected undesirable side effects, the Manufacturer is required to report any significant increase in the frequency or severity of the accident by means of Trend reports, to be sent to the competent Authorities.

  • Take corrective safety action: corrective safety action must be reported in Italian without undue delay through the Field Safety Corrective Action (FSCA) and the Field Safety Notice (FSN), before such corrective safety action is taken.

Public and private Healthcare Professionals who detect a serious or non-serious accident involving a Medical Device are required to report it to the Ministry of Health, to the Manufacturer or to its Authorised Representative also through the Distributor. In the case of a serious accident, the Healthcare Professional is required to report it as a matter of urgency and no later than 10 days; in the case of a non-serious accident, it is advisable to report it within 30 days. In the event of a complaint, the Healthcare Professional is required to make a report to the Manufacturer, also through the Distributor, and at the same time, to the Ministry of Health.

Finally, the device that is the subject of the accident must be returned to the Manufacturer 10 days after becoming aware of such accident.

The above indications may be subject to revision and modification: we will keep you informed in case of further developments or updates.

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