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

AUS Essential Principle 2:

AUS EP 2 Design and construction of medical devices to conform with safety principles

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.
2. Without limiting subclause (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:   

..........(d) Fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted.

EU MDR GSPR 4:

GSPR 4 Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art.

To reduce risks, manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable.

In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:

..........(c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.

Manufacturers shall inform users of any residual risks.

AUS Essential Principle 4 Long-term safety

A medical device must be designed and produced in a way that ensures that if:

1. The device is used within the period, indicated by the manufacturer, in which the device can be safely used; and
2. The device is not subjected to stresses that are outside the stresses that can occur during normal conditions of use; and
3. 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.

AUS Regulations Dictionary - Therapeutic Goods (Medical Devices) Regulations 2002:

device lifetime, in relation to a medical device, means the period, indicated by the manufacturer, during which:

(a)  the device can be safely used; and

(b)  the characteristics and performance of the device are not affected by its age.