Post market responsibilities

Laboratories must implement a post-market system for the ongoing monitoring of the performance of their in-house IVDs (e.g., via quality assurance programs and internal quality control) and to notify us of any adverse events.

The MD Regulations require laboratories that manufacture in-house IVDs to have a QMS in place that allows them to:

• monitor the performance of their IVDs by systematically reviewing the application of quality control (QC) procedures and participation in external quality assurance (EQA) programs
• apply necessary corrective action if any failures (or potential failures) are detected in relation to the performance of the in-house IVD
• report any adverse events relating to the safety, quality or performance of their in-house IVDs to us.
• notify us* of any malfunction or deterioration in a Class 4 in-house IVD that has led the laboratory to take steps to cease using or recover the device if it has been disseminated within a laboratory network.
• *Send this notification to the TGA Recalls Unit in accordance with the requirements of the Uniform Recall Procedure for Therapeutic Goods (URPTG).

The NPAAC standard (Sections 9 and 10 - Particular requirements - monitoring, analysis and improvement and Particular requirements - adverse event reporting and recalls) provides guidance on the necessary monitoring and post market activities for in-house IVD manufacturers.

Adverse events

An adverse event includes an event that leads to:

• the death of a patient
• a serious injury or serious deterioration to a patient, user or other person, including a life-threatening illness or injury
• permanent impairment of a body function
• permanent damage to a body structure
• a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Typical causes of adverse events

• design issues
• deficiencies in instructions
• defective components
• performance failures
• user/systemic errors

Reporting adverse events

The MD Regulations prescribe that information must be reported to us about events related to the use of medical devices (including in-house IVDs) that represent:

• a serious threat to public health
• the death of a person
• a serious deterioration in the health of a person.

Regulation 5.7 prescribes the timeframes where information about adverse events must be reported to us:

For further information on reporting adverse events for medical devices, see Report a medical device adverse event (sponsor/manufacturer).