SAE Reporting

Reporting of Serious Adverse Events (SAE)

The sponsor of a clinical investigation is obliged to record any serious adverse events (SAEs) and notify them immediately to the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) and to all other competent authorities in those member states of the European Economic Area in which the clinical investigation is being performed (Medical Devices Act – Medizinproduktegesetz (MPG) Article 42 (8)).

The clinical investigator is responsible for immediate reporting of serious adverse reactions occurring during a clinical investigation to the ethics committee (Article 61 MPG).

The clinical investigator must inform the sponsor of any device-related adverse reactions and SAEs occurring during a clinical investigation (Article 64 (5) MPG).

In addition, the notification requirements of Article 70 Medical Devices Act apply.

SAEs occurring in Austria must be reported to BASG using form F_I208 (Notification of Serious Adverse Events occurring during a clinical investigation with a medical device or during a performance evaluation – Meldung von schwerwiegenden unerwünschten Ereig¬nissen im Rahmen einer klinischen Prüfung mit einem Medizinprodukt bzw. einer Leistungs¬bewertungsprüfung).

All SAEs (no matter whether they occurred in Austria or abroad) must be summarized in a Line Listing using form F_I287 (SAE Report Table). Whenever new SAEs are received or follow-up or additional information on previously reported SAEs becomes available, an updated Line Listing has to be submitted to BASG immediately.

SAE Line Listings may also be submitted in a format other than F_I287 provided that:

• the Line Listing contains all of the information required by Form F_I287,
• the Line Listing contains a filter function (xls format),
• any changes compared to the previous version of the Line Listing are clearly marked or highlighted (new SAEs, changes to or follow-up information on previously reported SAEs),
• every SAE contained in the Line Listing can be unequivocally assigned to the study during which it occurred by means of the BASG reference number.

Please note:

• The new notification requirements entered into force on 21 March 2010. SAEs having occurred before 21 March 2010 for which no additional information has become available do not have to be reported retroactively.
• Each SAE listed in form F_I287 must carry the following information: a = added, new SAE/Complaint; m = modified, new information for this SAE/Complaint; u = unchanged, no new information for this SAE/Complaint (see notification form F_I287).
• The format and content of notification form F_I287 were developed in consultation with the relevant bodies of the European Commission. The MEDDEV Guideline 2.7/3 "Clinical Investigation: serious adverse event reporting" including the "SAE reporting form" have been published by the European Commission in December 2010.

For clinical investigations initiated before the coming into force of the Austrian Medical Devices Act (MPG), i.e., before 1 January 1997 (Federal Gazette No. 657/1996), the transitional provisions of MPG § 112 (4) shall apply; such investigations can continue to be performed in accordance with the regulations valid at the time they were started.

SAE reports can be submitted by postal mail (BASG, Institute Inspections, Medical Devices & Haemovigilance – Institut Inspektionen, Medizinprodukte & Hämovigilanz, Schnirchgasse 9, 1030 Vienna, Austria) or electronically (E-Mail: inspektionenagesat). Please choose between mail or electronic submission to avoid duplicate notifications.

Note: When submitting SAE reports electronically, you will receive an automatic reply message. Should you fail to receive such a reply email, please resubmit your documentation or contact us. Some emails may be rejected by the BASG spam filter for no obvious reason.