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Regulatory requirements for in-house IVDs

Version 2.2, September 2018

11 September 2018

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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:

Event (or other occurrence) Timeframe required for reporting (after the person becomes aware of the event or occurrence)
Represents a serious threat to public health 48 hours

Led to the death, or a serious deterioration in the state of health, of a person*

*a patient, a user of the device, or another person

10 days

Where a recurrence might lead to the death or a serious deterioration in the state of health, of a person*

*a patient, a user of the device, or another person

30 days

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

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