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

NEW
(No equivalent)

MDR GSPR 23.2(a)

IVDR GSPR 20.2(a)

For all devices:

• Include the name of the device

Item 1

MDR GSPR 23.2(c)

IVDR GSPR 20.2(c)

For all devices:

• Clarify that the manufacturer’s address must be their registered place of business (i.e., not a PO Box)

NEW
Item 2,3

MDR GSPR 23.2(b)

IVDR GSPR 20.2(b,j)

For IVD devices:

• Clarify that information be included, where relevant, such as an indication of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of thereof, or other terms which accurately reflect the contents of the package.

Item 5

MDR GSPR 23.2(m)

IVDR GSPR 20.2(m)

For all devices:

• Clarify that critical information, that needs to be brought to the immediate attention of the user, or any other person,  to be clearly evident.
• Clarify that critical information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users.

NEW
Item 9

MDR GSPR 23.2(q)

IVDR GSPR 20.2(e)

For all devices:

• Include an indication that the device is a medical device or an IVD device, as applicable.

NEW
(No equivalent)

For non-IVD devices:

• For devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, include information on the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action.

NEW
Item 10

MDR GSPR 23.2(l)

IVDR GSPR 20.2(l)

For all devices:

• Devices with a specific microbial state to include a statement indicating any special microbial state or state of cleanliness.

Note: "Specific microbial state” is proposed for adopting, for both IVD devices and other medical devices, under Proposal 4 (EP 8.3/MDR GSPR 11.3/IVDR GSPR 11.2). 

Item 12

MDR GSPR 23.2(i)

IVDR GSPR 20.2(h)

For all devices:

• Provide clarity by adding “without degradation of performance”.

NEW
(No equivalent)

For non-IVD devices:

• Where applicable, labelling to indicate that the device contains or incorporates:
  • a medicinal substance, including human blood or plasma or derivatives
  • tissue or cells or animal origin, or their derivatives

Note: We will not adopt the MDR clause regarding tissues, cells, or their derivatives, of human origin for non-IVD devices, as these fall under our Biologicals Regulatory Framework.

NEW
(No equivalent)

MDR GSPR 23.2(h)

IVDR GSPR 20.2(g)

For all devices:

• Include the unique device identifier (UDI)

Note: This requirement is being progressed as part of our existing UDI reforms project which is ongoing.

NEW
(No equivalent)

For non-IVD devices:

• Active implantable to have the serial number.
• Other implantable devices to have the serial number or lot number.

NEW
(No equivalent)

For IVD devices:

• If the device is intended for self-testing or near-patient testing, an indication of that fact.

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(No equivalent)

For IVD devices:

• Rapid assays not intended for self-testing or point-of-care testing must explicitly exclude their use for such purposes.

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(No equivalent)

For IVD devices:

• Where components of a kit are available as separate devices, each of those devices must comply with the relevant AUS Essential Principles, including AUS EP 13.

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(No equivalent)

For IVD devices:

• The device and any separate components are to be traceable in terms of batches.
• As far as practicable and appropriate, the information shall be set out on the device itself and/or, where appropriate, on the sales packaging.

NEW
(No equivalent)

For IVD devices:

• Labelling requirements for self-testing IVD devices to include the following particulars
  • the type of specimen(s) required to perform the test (e.g. blood, urine or saliva);
  • the need for additional materials for the test to function properly;
  • contact details for further advice and assistance
• The name of the device for self-testing is not to reflect an intended purpose other than that intended by the manufacturer.

NEW
(No equivalent)

MDR GSPR 23.3

 IVDR GSPR 20.3

The requirements within GSPRs 23.2(MDR) and 20.3(IVDR) are specifically regarding information that must be included on the packaging of devices supplied sterile.

For all devices supplied sterile:

• An indication permitting the sterile packaging to be recognised as such.
• A declaration that the device is in a sterile condition.
• The method of sterilisation.
• The name and address of the manufacturer.
• A description of the device.
• The month and year of manufacture.
• An unambiguous indication of the time limit for using or implanting the device safely. expressed at least in terms of year and month
• An instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.

For non-IVD devices supplied sterile:

• If the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’.
• If the device is custom-made, the words ‘custom-made device’.