Producing and manufacturing is of greatest concern to the Regulatory Authorities in South Africa.
Below are six general Essential Principles of Safety and Performance that apply to all medical devices. There are a further nine Essential Principles of Safety and Performance about design and construction that apply to devices on a case-by-case basis.
- the device will not compromise the clinical condition or safety of a patient, or the safety and health of the user or any other person, when the device is used on a patient under the conditions and for the purposes for which the device was intended and, if applicable, by a user with appropriate technical knowledge, experience, education or training; and
- any risks associated with the use of the device are:
- acceptable risks when weighed against the intended benefit to the patient; and
- compatible with a high level of protection of health and safety.
The solutions adopted by the manufacturer for the design and construction of a medical device must conform with safety principles, having regard to the generally acknowledged state of the art.
Without limiting subsection (1), in selecting appropriate solutions for the design and construction of a medical device so as to minimise any risks associated with the use of the device, the manufacturer must:
- first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse of the device; and
- second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction; and
- third, if appropriate, ensure that adequate protection measures are taken, including alarms if necessary, in relation to any risks that cannot be eliminated; and
- fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted.
- perform in the way intended by the manufacturer; and
- be designed, produced and packaged in a way that ensures that it is suitable for one or more of the purposes mentioned in the definition of medical device in the Medicines and Related Substances Act, 1965 (Act 101 of 1965).
- the device is used within the period, indicated by the manufacturer, in which the device can be safely used; and
- the device is not subjected to stresses that are outside the stresses that can occur during normal conditions of use; and
- the device is regularly maintained and calibrated in accordance with the manufacturer’s instructions;
- the characteristics and performances mentioned in clauses 1, 2 and 3 are not adversely affected.
A medical device must be designed, produced and packed in a way that ensures that the characteristics and performance of the device when it is being used for its intended purpose will not be adversely affected during transport and storage that is carried out taking account of the instructions and information provided by the manufacturer.
The benefits to be gained from the use of a medical device for the performance intended by the manufacturer must outweigh any undesirable effects arising from its use.
- the chemical and physical properties of the materials used in the device; and
- the compatibility between the materials used and biological tissues, cells, body fluids and specimens;
- having regard to the intended purpose of the device.
- is compatible with the provisions and restrictions applying to the medicine to be administered; and
- allows the medicine to perform as intended.
- the safety and quality of the substance must be verified in accordance with the requirements for medicines; and
- the ancillary action of the substance must be verified having regard to the intended purpose of the device.
- allows it to be easily handled; and
- if appropriate, minimises contamination of the device or specimen by the patient, user or other person by the device or specimen.
- Tissues, tissue derivatives, cells or substances of animal origin that have been rendered non- viable; and
- tissues, tissue derivatives, cells or substances of microbial or recombinant origin.
- ensures that the risk of microbial contamination is minimised; and
- is suitable, having regard to the method of sterilisation that the manufacturer indicates is to be used for the device.
- the medical device, and any other device or equipment with which it is used, operate in a safe way; and
- the intended performance of the device, and any other device or equipment with which it is used, is not impaired.
- the risk of injury arising from the physical features of the device;
- any risks associated with reasonably foreseeable environmental conditions;
- the risk of reciprocal interference involving other devices that are normally used in an investigation or treatment of the kind for which the device is intended to be used;
- any risks arising if maintenance or calibration of the device is not possible;
- any risks associated with the ageing of materials used in the device;
- any risks associated with loss of accuracy of any measuring or control mechanism of the device;
- the risk of fire or explosion occurring during normal use of the device, and in the event of a single fault condition, especially if the device is intended to be exposed to flammable substances or substances that can cause combustion;
- the risks associated with disposal of any waste substances.
A medical device that has a measuring function must be designed and produced in a way that ensures that the device provides accurate, precise and stable measurements within the limits indicated by the manufacturer and having regard to the intended purpose of the device.
The measurement, monitoring and display scale of the device must be designed and produced in accordance with ergonomic principles, having regard to the intended purpose of the device.
The measurements made by the device must be expressed:
- in South African legal units of measurement; or
- if the device measures a physical quantity for which no South African legal unit of measurement has been prescribed under the requirements of the Trade Metrology Act and Regulations, 1973 (Act 77 of 1973), and the Measuring Units and National Measuring Standards Act, 1973 (Act 76 0f 1973).
Minimisation of exposure to radiation
This Essential Principle is intended to cover all forms of radiation.
A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to radiation is minimised, having regard to the levels of radiation required to enable the device to perform its therapeutic and diagnostic functions and the intended purpose of the device.
Medical devices intended to emit radiation
This applies to a medical device that is intended by the manufacturer to emit hazardous levels of visible or invisible radiation because the emission is necessary for a specific medical purpose, the benefit of which is considered to outweigh the risks inherent in the emission.
The device must be designed and produced in a way that ensures that the user can control the level of the emission.
The device must be designed and produced in a way that ensures the reproducibility and tolerance of relevant variable parameters.
If practicable, the device must be fitted with a visual indicator or an audible warning, or both, that operates if potentially hazardous levels of radiation are emitted.
Minimisation of exposure to unintended radiation
A medical device must be designed and produced in a way that ensures that the exposure of a patient, the user, or any other person, to the emission of unintended, stray or scattered radiation is minimised.
The operating instructions for a medical device that emits radiation must include detailed information about the following matters:
- the nature of the radiation emitted;
- the means by which patients and users can be protected from the radiation;
- ways to avoid misusing the device;
- ways to eliminate any risks inherent in the installation of the device
Medical devices intended to emit ionising radiation - additional requirements
In addition to all the above, the device must be designed and produced in a way that ensures that, if practicable, the quantity, geometry and energy distribution (or quality) of radiation emitted can be controlled and varied, having regard to the intended purpose of the device.
If the device is intended to be used for diagnostic radiology, the device must be designed and produced in a way that ensures that, when used in relation to a patient for a purpose intended by the manufacturer:
- the device achieves an appropriate image or output quality for that purpose; and
- the exposure of the patient, or the user, to radiation is minimised.
If the device is intended to be used for therapeutic radiology, the device must be designed and produced in a way that ensures that the delivered dose of radiation, the type and energy of the radiation beam and, if appropriate, the energy distribution of the radiation beam can be reliably controlled and monitored.
- IEC 60601: a family of standards relating to the safety and performance of medical electrical equipment
- IEC 62304: Medical device software—Software life cycle processes
- AS ISO 9918: Capnometers for use with humans—Requirements
- AS ISO 9703: Anaesthesia and respiratory care alarm signals
- ISO 5356: Anaesthetic and respiratory equipment
- the performance, reliability, and repeatability of the system are appropriate for the intended purpose of the device; and
- any consequent risks associated with a single fault condition in the system are minimised.
- battery powered
- gas powered
- liquid or solid fuels
- addressing the safety issue as a part of the risk analysis and indicating what control measures are in place to reduce the risk to the patient
- documenting how the visual and audible alarms are designed and tested as a part of the technical documentation
- providing information about the visual and audible alarms as a part of the Instructions for Use
- the delivered rate and amount of energy, or of the substance, can be set and maintained accurately to ensure the safety of the patient and the user; and
- as far as possible, the accidental release of dangerous levels of energy or of the substance is prevented.
- the type of device; and
- the manufacturer of the device; and
- the year of manufacture of the device.
- information identifying the device;
- information identifying the manufacturer of the device;
- information explaining how to use the device safely;
- having regard to the training and knowledge of potential users of the device.
- In particular:
- the information required by section below regarding informatio to be supplied with medical devices (as a label) must be provided with a medical device; and
- if instructions for use of the device are required under the subsection below regarding instructions for use, the information mentioned in the subsection below regarding instructions for use for medical devices must be provided in those instructions.
- on the package used for the device; or
- in the case of devices that are packaged together because individual packaging of the devices for supply is not practicable – on the outer packaging used for the devices.
- the device is a Class A medical device and
- the device can be used safely for its intended purpose without instructions.
- the medical device achieves its intended purpose(s) during normal conditions of clinical use
- the known and foreseeable clinical risks and any adverse effects have been minimised
- the risk of using the medical device is acceptable when weighed against the benefits inherent in the intended purpose(s)
- any clinical claims about the device’s performance and safety (for example on the label and the Instructions for Use) are supported by clinical data.
An IVD medical device must be designed and manufactured in a way in which the analytical and clinical characteristics support the intended use, based on appropriate scientific and technical methods.
An IVD medical device must be designed in a way that addresses accuracy, precision, sensitivity, specificity, stability, control of known relevant interference and measurement of uncertainty, as appropriate.
If performance of an IVD medical device depends in whole or part on the use of calibrators or control materials, the traceability of values assigned to the calibrators or control material must be assured through a quality management system.
An IVD medical device must, to the extent reasonably practicable, include provision for the user to verify, at the time of use, that the device will perform as intended by the manufacturer.
An IVD medical device for self-testing must be designed and manufactured so that it performs appropriately for its intended purpose, taking into account the skills and the means available to usersand the influence resulting from variation that can reasonably be anticipated in the user’s technique andenvironment.
The information and instructions provided by the manufacturer of an IVD medical device for self-testing must be easy for the user to understand and apply.
An IVD medical device for self-testing must be designed and manufactured in a way that reduces, to the extent practicable, the risk of error in the use of the device, the handling of the sample and the interpretation of results.