| (1) |
The instructions for use must contain the following in at least English: |
| (a) |
The name or trade name; |
| (b) |
the name and address of the manufacturer; |
| (c) |
the intended purpose and use, including but not limited to |
| (iii) |
the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate; |
| (iv) |
whether it is automated or not; |
| (v) |
whether it is qualitative or quantitative; |
| (vi) |
the type of specimens required (e.g. serum, plasma, whole blood, tissue biopsy, urine); and |
| (vii) |
testing population; |
| (d) |
an indication that it is for in vitro diagnostic use and, where relevant, for "professional use only", for "near patient testing", for "point of care", for "self- testing" or for "research use only"; |
| (e) |
the intended user, as appropriate; |
| (g) |
a description of the reagent, calibrators and controls and any limitation upon their use (e.g. suitable for a dedicated instrument only); |
Note: IVD kits include individual reagents and articles that may be made available as separate IVDs. In this situation, where appropriate, these IVDs should comply with the instructions for use content in this section;
| (h) |
the composition of the reagent product by nature and concentration of the active ingredients of the reagents or kit as well as a statement, where appropriate, that the medical device contains other ingredients which might influence the measurement; |
| (i) |
a list of materials provided and a list of special materials required but not provided; |
| (j) |
for IVDs intended for use together with other IVDs or medical devices, or general purpose equipment— |
| (i) |
information to identify such medical devices or equipment, in order to obtain a safe combination; and |
| (ii) |
information on known restrictions to combinations of medical devices and equipment; |
| (k) |
an indication of any special storage and handling conditions that apply; |
| (I) |
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; |
| (m) |
if the IVD is supplied as sterile, instructions in the event of the sterile packaging being damaged before use; |
| (n) |
information that allows the user to be informed of warnings, precautions, measures to be taken and limitations of use regarding the IVD, which information must cover, where appropriate— |
| (i) |
warnings, precautions and measures to be taken in the event of malfunction of the IVD or its degradation as suggested by changes in its appearance that may affect performance; |
| (ii) |
warnings, precautions and measures to be taken with regard to the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature; |
| (iii) |
warnings, precautions and measures to be taken with regard to the risks of interference posed by the reasonably foreseeable presence of the medical device during specific diagnostic investigations, evaluations, therapeutic treatment including electromagnetic interference emitted by the medical device affecting other equipment, where applicable; and |
| (iv) |
precautions related to materials incorporated into the IVD that are carcinogenic, mutagenic or toxic, or could result in sensitisation or allergic reaction; |
| (o) |
warnings and precautions related to potentially infectious material that is included in the IVD; |
| (p) |
where relevant, requirements for special facilities including clean room environment, radiation safety or particular qualifications of the medical device user; |
| (q) |
conditions for collection, handling, and preparation of the specimen; |
| (r) |
details of any preparatory treatment or handling of the IVD before it is ready for use including reconstitution and calibration where applicable; |
| (s) |
the information needed to verify whether the IVD is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant— |
| (i) |
details of the nature, and frequency, of preventative and regular maintenance including cleaning and disinfection; |
| (ii) |
identification of any consumable components and how to replace them; |
| (iii) |
information on any necessary calibration to ensure that the IVD operates properly and safely during its intended life span; and |
| (iv) |
methods of mitigating the risks encountered by persons involved in installing, calibrating or servicing an IVD; |
| (t) |
where relevant, recommendations for quality control procedures; |
| (u) |
the metrological traceability of values assigned to calibrators and trueness-control materials, including identification of applicable reference materials and reference measurement procedures of higher order; |
| (v) |
assay procedure including calculations and interpretation of results and where relevant if any confirmatory testing must be considered; |
| (w) |
analytical performance characteristics, such as sensitivity, specificity, and accuracy; |
| (x) |
where relevant, clinical performance characteristics, such as diagnostic sensitivity and diagnostic specificity; |
| (y) |
where relevant, reference intervals; |
| (z) |
information on interfering substances or limitations such as visual evidence of hyperlipidaemia or haemolysis, age of specimen that may affect the performance of the assay; |
| (aa) |
warnings or precautions to be taken related to the disposal of the medical device, its accessories, and the consumables used with it, if any, which information must cover, where appropriate— |
| (i) |
infection or microbial hazards; |
| (ii) |
environmental hazards; and |
| (bb) |
for an IVD intended for use by a lay person, the circumstances when the user must consult with a healthcare professional; |
| (cc) |
where relevant, a bibliography; |
| (dd) |
the date of issue or latest revision of the instructions for use and, where appropriate, an identification number; and |
| (ee) |
appropriate maintenance instructions for technical IVD machines, where applicable. |
| (2) |
Instructions for the use of an IVD must be included with the sale of each IVD, however, instructions for use for Class A IVDs must be included, where applicable. |
Statistics Act, 1999
