Essential Principles
Information & Training. | Medical Devices.
Principle 1 – Use of a medical device must not compromise health and safety.
From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 1
A medical device is to be designed and produced in a way that ensures that:
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.
Medical Device Requirements. How to demonstrate Compliance.
A fundamental concept in the design and production of a medical device is how the device is intended to be safely used and by whom. A manufacturer is required to undertake a well-reasoned and documented analysis of the foreseeable risks that could occur by using the device and compare these with a well-reasoned and documented analysis of the benefits that would be provided for the patient or user of the medical device. These analyses have to recognise that a patient or user’s safety is paramount.
The work undertaken by the manufacturer could involve, but is not restricted to:
- a well-reasoned and documented risk analysis
- a documented review of relevant published literature
- a documented review of manufacturer’s experience with device
- assessing and documenting compliance of the device and its packaging with specifications and standards
- reviewing and documenting the labelling and Instructions for Use provided with the device
- reviewing and documenting final release procedures
Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>
Principle 2 – Design and construction of medical devices to conform with safety principles.
From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 1
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 sub clause (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.
Medical Device Requirements. How to demonstrate Compliance.
The design and construction processes for a medical device need to take account of any foreseeable risks or hazards that may exist, or could be created by the device when it is used as intended by the manufacturer. The design and construction of the device should, wherever possible, eliminate the identified risks or hazards. Where risks or hazards can not be avoided methods must be established to alert and inform users of the medical device.
As for Essential Principle 1, a well-reasoned and documented risk analysis should be developed to demonstrate compliance with Essential Principle 2. It is also important to regularly update the risk analysis of the device to account for changes in knowledge or advances in the field to ensure that the design and construction of the medical device continues to conform to safety principles.
Compliance with the relevant Australian and international standards are generally accepted as meeting subclause (1) of this Essential Principle. However, the manufacturer may choose alternate methods for design, construction and testing. If the device does not comply with any relevant Australian and/or international standards, justification should be provided to explain why the manufacturer has made this decision.
The work undertaken by the manufacturer could involve, but is not restricted to:
- a well-reasoned and documented risk analysis
- a documented review of manufacturer’s experience with device
- documented compliance and/or consideration of relevant product safety and performance standards
Principle 3 – Medical devices to be suitable for intended purpose.
From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 1
A medical device must:
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 subsection 41BD (1) of the Act.
Medical Device Requirements. How to demonstrate Compliance.
The work undertaken by the manufacturer could involve, but is not restricted to:
- appropriate test protocols and results to demonstrate that the design, production and packaging of the device enables it to perform as intended
- where the manufacturer makes specific claims in relation to, for example, antimicrobial efficacy of the medical device, appropriate data should support the claims
- where the manufacturer is operating an appropriate and certified quality system, this Essential Principle will be partly addressed by that certification
Principle 4 – Long-term safety.
From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 1
A medical device must be designed and produced in a way that ensures that if:
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 previously are not adversely affected.
Medical Device Requirements. How to demonstrate Compliance.
The manufacturer needs to have evidence that the design and production practices used for their medical device have taken into account the following to ensure that the device continues to comply with Essential Principles 1, 2, and 3:
- the expected lifetime of the device
- identified stresses experienced by the medical device during normal use
- any regular maintenance and calibration requirements
The lifetime of a device is considered to include the period prior to first use, and the period (or number of uses) expected or recommended by the manufacturer. Assessment of this can be done by bench testing, simulated shelf life testing and clinical evaluation.
The work undertaken by the manufacturer could involve, but is not restricted to:
- a well-reasoned and documented risk analysis
- assessment of lifetime of the device including bench testing, simulated shelf life testing and clinical evaluation
- a documented review of complaint history
- clinical evidence
Principle 5 – Medical devices not to be adversely affected by transport or storage.
From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 1
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.
Medical Device Requirements. How to demonstrate Compliance.
The work undertaken by the manufacturer could involve, but is not restricted to:
- documented evidence of testing to demonstrate that the design, production and packaging of the device ensure that the device characteristics and performance is not adversely effected during transport and storage
- a documented review of complaint history
Principle 6 – Benefits of medical devices to outweigh any undesirable effects.
From the Therapeutic Goods (Medical Devices) Regulations 2002—Schedule 1, Part 1
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.
Medical Device Requirements. How to demonstrate Compliance.
To comply with this Essential Principle it is necessary, as part of a well-reasoned risk analysis, to identify and document any undesirable effects from using the device and compare these with the benefits expected to be achieved through the use of the device.In addition to the risk analysis, manufacturers should provide evidence that the outcomes or conclusions of the risk analysis have been acted on.
The work undertaken by the manufacturer could involve, but is not restricted to:
- a well-reasoned and documented risk analysis
- a documented review of the manufacturer’s experience with device
Information & Training.
Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>