Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation

EP 15(1,2)

• Expand the clarity provided, that analytical performance, includes trueness, precision,  accuracy, limits of detection and quantitation, measuring range, linearity, cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference, cross reactions.
• Include clarify that clinical performance; specifically refers to diagnostic sensitivity, diagnostic specificity as well additionally includes positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations.

NEW
(No equivalent)

• To clarify that performance characteristics of the device shall be maintained during the lifetime of the device, as indicated by the manufacturer.

While AUS EP 4 covers long-term safety of devices, this principle will be included again under AUS EP 15.

NEW
EP 15(3)

• Require metrological traceability of values assigned to calibrators and/or control materials to be assured through suitable reference measurement procedures and/or suitable reference materials of a higher metrological order.
• Where available, metrological traceability of values assigned to calibrators and control materials shall be assured to certified reference materials or reference measurement procedures.

• Require the characteristics and performances of the device to be specifically checked in the event that they may be affected when the device is used for the intended use under normal conditions:
  • for devices for self-testing, performances obtained by laypersons;
  • for devices for point-of-care testing, performances obtained in relevant environments (for example, patient home, emergency units, ambulances).

IVDR GSPRs 10-18 are aligned with existing Essential Principles, outside of EP 15:

GSPR 10 – refer to EP 7 (Proposal 3)

GSPR 11-12 – refer to EP 8 (Proposal 4)

GSPR 13 – refer to EP 9 (Proposal 5)

GSPR 14 – refer to EP 10 (No changes)

GSPR 15 – refer to EP 11 (Proposal 6)

EP 15(5, 6)

• Expand the scope of both EP 15 (5) and (6) to include devices for point of care testing.
• Clarify the expectation that characteristics and performance of the device are to be evaluated by the manufacturer to ensure the device performs as intended, taking into account the intended user and intended use environment.
• Clarify that the information and instructions provided be easy for the user to understand so they can correctly interpret the result provided by the device and to avoid misleading information.
• Require devices intended for point of care testing, the information and the instructions provided by the manufacturer shall make clear the level of training and/or experience required by the user.

EP 15(7)

• Increase the scope to include devices for point of care testing.
• Clarify the requirement that design and manufacture are to ensure that:
  • the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary, after appropriate training and/or information
  • the risk of error by the intended user in the handling of the device and, if applicable, the specimen, and also in the interpretation of the results, are minimised.