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

NEW
(No equivalent)

GSPR 20.4.1(c)

• Details for the intended purpose for IVD devices are to include:
  • (i) what is detected and/or measured;
  • (ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic);
  • (iii) the specific information that is intended to be provided in the context of:
    • a physiological or pathological state;
    • congenital physical or mental impairments;
    • the predisposition to a medical condition or a disease;
    • the determination of the safety and compatibility with potential recipients;
    • the prediction of treatment response or reactions;
    • the definition or monitoring of therapeutic measures;
  • (iv) whether it is automated or not;
  • (v) whether it is qualitative, semi-quantitative or quantitative;
  • (vi) the type of specimen(s) required;
  • (vii) where applicable, the testing population; and
  • (viii) for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test.

NEW
(c)

GSPR 20.4.1(h)

• Include ingredient(s) of the reagents(s) or kit.

NEW
(d)

GSPR 20.4.1(v,y)

• Include, where relevant, if any confirmatory testing shall be considered.
• Include, where relevant, information regarding batch to batch variation provided with relevant figures and units of measure.
• Calculations are to include the mathematical approach upon which the calculation of the analytical result is made.

NEW
(e)

GSPR 20.4.1(ab)

• Include information on limitations that may affect the performance of the device, with examples for clarity.

(f)

GSPR 20.4.1(w)

• Clarify requirements for analytical performance by including equivalent detail and examples such as but not limited to analytical sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and measurement range, (information needed for the control of known relevant interferences, cross-reactions and limitations of the method), measuring range, linearity and information about the use of available reference measurement procedures and materials by the user.

(g)

GSPR 20.4.1(x,z)

• Clarify information required for clinical performance characteristic by including examples, such as, but not limited to:
  • threshold value, diagnostic sensitivity and diagnostic specificity, positive and negative predictive value.
  • diagnostic sensitivity, diagnostic specificity, likelihood ratio, expected values in normal and affected populations.

(h)

GSPR 20.4.1(aa)

• Clarify "reference intervals" by including “in normal and affected populations”.

(i)

GSPR 20.4.1(o) & ac(i)

• Include reference to risk of microbial hazards, such as, but not limited to, consumables contaminated with potentially infectious substances of human origin.

NEW
(No equivalent)

GSPR 20.4.1(g, i, l, t)

• Include a description of the calibrators and controls and any limitations upon their use.
• Include a list of materials provided and a list of special materials required but not provided.
• Include in-use stability which may include the storage conditions, and shelf life following the first opening of the primary container, together with the storage conditions and stability of working solutions, where this is relevant.
• Where applicable, include recommendations for quality control procedures.

NEW
(No equivalent)

GSPR 20.4.1(u) 

• Include the metrological traceability of values assigned to calibrators and control materials, including identification of applied reference materials and/or reference measurement procedures of higher order and information regarding maximum (self-allowed) batch to batch variation provided with relevant figures and units of measure;

NEW
(No equivalent)

GSPR 20.4.1(ag)

• Require any components within an IVD kit that are available as separate devices, must individually comply with the AUS Essential Principles.

NEW
(No equivalent)

GSPR 20.4.2
(a-g)

For IVD devices intended for self-testing:

• The instructions for use must contain, as a minimum, the information below:
  • (a) details of the test procedure shall be given, including any reagent preparation, specimen collection and/or preparation and information on how to run the test and interpret the results;
  • (b) specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to use the device and to understand the result(s) produced by the device;
  • (c) the device's intended purpose shall provide sufficient information to enable the user to understand the medical context and to allow the intended user to make a correct interpretation of the results;
  • (d) the results shall be expressed and presented in a way that is readily understood by the intended user;
  • (e) information shall be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result), on the test limitations and on the possibility of false positive or false negative result. Information shall also be provided as to any factors that can affect the test result such as age, gender, menstruation, infection, exercise, fasting, diet or medication;
  • (f) the information provided shall include a statement clearly directing that the user should not take any decision of medical relevance without first consulting the appropriate healthcare professional, information on disease effects and prevalence, and, where available, information specific to the Member State(s) where the device is placed on the market on where a user can obtain further advice such as national helplines, websites;
  • (g) for devices intended for self-testing used for the monitoring of a previously diagnosed existing disease or condition, the information shall specify that the patient should only adapt the treatment if he has received the appropriate training to do so.
• AUS-specific: If specific particulars of AUS EP 13.4(3)29 are omitted, as permitted under GSPR 20.4.2(b), the omitted information must be available and presented to the Secretary upon request according to the legislated timeframes for such requests.

Where the GSPR refers to (EU) Member States, the Australian legislation will refer to the appropriate Australian department/s.