CASafetyReporting object

Sponsor

SAE (Serious Adverse Event)
SAE (Serious Adverse Event) including AE being life-threatening or leading to death or to a serious deterioration in health, prolonged hospitalisation, additional surgery or medical intervention
Device deficiency, that might have led to SAE if no action or intervention had been made

The HPRA contact address for SAE reporting of clinical investigations will be communicated directly to the sponsor

No

Reporting to HPRA should follow instructions given in the ‘Guide for Manufacturers and Sponsors on Clinical Investigations Carried out in Ireland’ (available on the HPRA website in section: About Us > Publications&Forms > Guidance Documents

MEDDEV 2.7/3 provides additional guidance regarding the reporting of serious adverse events during a clinical investigation including timelines for reporting to national competent authorities. The HPRA accept summary tabulations of serious adverse events as outlined in this document, however may request more specific information on specific serious adverse events if deemed necessary.

Yes

Any serious adverse event (SAE) involving a device under clinical investigation within the scope of the Directives should be reported to the HPRA as required by the Medical Devices Regulations 1994, S.I. No. 252 of 1994 as amended and S.I. No. 253 of 1994 as amended and in accordance with MEDDEV 2.7/3.

- Reporting timelines: Timelines for reporting may occasionally be amended by HPRA, depending on the nature of the clinical investigation by notification of HPRA to the sponsor.

- Annual safety report: Annual safety report is not needed for clinical investigations unless it is specifically requested as a condition to the ‘letter of no objection’.

- Post market clinical follow-up study on a CE marked device used within its indication: the sponsor of this study should report according to the MEDDEV guidance series 2.12 on market surveillance.