CASafetyReporting object

Sponsor

Competent Authority
Relevant EC(s)
Investigators shall also be notified

SAE (Serious Adverse Event) arising from the testing of the MD

Immediately

Yes
European standard SAE reporting form MEDDEV 2.7/3 to be used

Serious Adverse Event Reporting Form: Electronically completed and signed with a certified electronic signature in the Czech or English language.

Yes

National CA
Relevant EC(s)
(no later than by 31 January of the following year)

Related details are available on the SUKL website in section: Medical Devices / Clinical evaluation of medical devices / Serious Adverse Event (SAE) reporting.
The particulars of Serious Adverse Event reporting to the Institute are set forth by Section 2 of Decree No 62/2015 Coll., implementing some provisions of the Act on Medical Devices.

Section 19 of Act No 268/2014 on Medical Devices
Section 2 of Decree No 62/2015

(1) Where the clinical investigation is conducted using also medical devices for which conformity has been assessed (which are CE-marked) and during their use an event occurred which resulted or could result in a serious deterioration of the state of health or death, such events shall be reported as adverse incidents in compliance with Section 70 of the Act on Medical Devices.

(2) SAE reporting obligations in a clinical investigation of a MD commenced prior to the effective date of the new Act on Medical Devices and uncompleted by this date: Requirements specified on SUKL website in section: Medical Devices / Clinical evaluation of medical devices / Serious Adverse Event (SAE) reporting.

Sponsor

Immediately

Yes