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

Closes 13 Nov 2024

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Proposal 9: Amend AUS Essential Principle 13.1 (General labelling)

The proposed changes are included under "more information".  The full legislative text comparison and the proposals are presented together in Attachment 1.

Proposal 9(a). Do you agree with the proposal to adopt the intent of the EU GSPRs, related to AUS Essential Principle 13.1?

More information

AUS Essential Principle 13.1 Information to be provided with medical devices - general

AUS EP Reference  Related EU GSPR Proposed changes

NEW
EP 13.1(1, 2)

MDR GSPR 23.1

IVDR GSPR 20.1

For all devices:

  • Require performance information relevant to the user or any other person be included.

EU GSPRs related to electronic instructions for use (IFU) are outside the scope of this consultation.

Electronic IFUs are part of our ongoing reforms. Once a policy decision has been made, these EU GSPRs will be reconsidered for adoption, if appropriate.
NEW
EP13.1(3)

MDR GSPR 23.1(c)

IVDR GSPR 20.1(c)

For all devices:

  • Include the option for information required by EP 13 to also be provided in a machine-readable format.

An AUS-specific requirement related to this proposal is included under 9(b).

EP 13.1 (4)

MDR GSPR 23.1(a)

IVDR GSPR 20.1(a)

For all devices:

  • Clarify that consideration be given to the technical knowledge, experience and training of the intended users.
NEW

MDR GSPR 23.1(e)

IVDR GSPR 20.1(e)

For all devices:

  • Where multiple devices, with the exception of devices intended for self-testing or point of care testing, are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.

An AUS-specific requirement related to this proposal is included under 9(e).

NEW
(No equivalent)

MDR GSPR 23.1(g)

IVDR GSPR 20.1(g)

For all devices:

  • Require information on any residual risks to be provided as limitation, contra-indications, precautions or warnings

Although this is an addition to AUS EP 13.1, it is not a new requirement. Informing users of residual risks is a requirement of AUS Essential Principle 2.

NEW
(No equivalent)

IVDR GSPR 20.1(i)

For IVD devices:

  • Require relevant hazard pictograms and labelling requirements (as required by relevant Australian legislation) for any device containing substances or mixtures which may be considered as dangerous goods. 

Depending on legislative drafting requirements, reference may be made to the regulations and requirements for hazardous chemical labels, in Australia, such as the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals[1]for the classification of hazardous chemicals.

 

[1] Globally Harmonised System (GHS) of Classification and Labelling of Chemicals: http://unece.org/ghs-rev7-2017

 

NEW
(No equivalent)

 

.

IVDR GSPR 20.1(j)

 

For IVD devices:

  • Require compliance with relevant safety requirements related to dangerous substances.

Reference may be made to regulations and requirements for hazardous chemical labels, in Australia, such as those detailed in Safe Work Australia’s Information on hazardous chemicals[1].

 

MATRIX response option

Please clarify your response to individual proposals below.
Proposal 9(b). AUS-specific: Do you agree with the proposal to allow information required under AUS Essential Principle 13.1(3) to be supplemented by machine-readable information providing such information does not interfere with the performance of the device or the device’s ability to meet the AUS Essential Principles?

AUS-specific proposal

Proposal 9(b) relates to alignment with EU GSPR 23.1(c), to allow information to also be provided in a machine-readable format. The AUS-specific proposal relates to reducing risks from any potential interference from such formats on the intended performance of the device.

More information

EU MDR GSPR 23.1(c) & IVDR GSPR 20.1(c) 

Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification or bar codes.

Proposal 9(c). AUS-specific: For AUS Essential Principle 13.1(5), do you agree that legibility would be better defined by referring to a specific font type and size rather than “a minimum of 1mm”, such as equivalent to at least 8pt Times New Roman?

AUS-specific proposal

AUS-specific proposal: Legibility
The EU GSPRs do not specify what constitutes "legible", whereas the AUS Essential Principles specify:

AUS Essential Principle 13.1(5) Any number, letter, symbol, or letter or number in a symbol, used in the information must be legible and at least 1 millimetre high.

The TGA has had complaints that the “1mm” requirement does not always result in information being legible. We consider it more appropriate to refer to a FONT TYPE and SIZE, or equivalent, to be considered “legible”. For example, font and size to be at least equivalent to 8pt Times New Roman.

Proposal 9(d). AUS-specific: For AUS Essential Principle 13.1(5), do you agree that legibility should incorporate consideration of text contrast against background for warnings, precautions and contraindications required to be brought to the attention of the user?
Proposal 9(e). AUS-specific: Do you agree that devices intended for use by lay persons (using the amended definition under Proposal 15) all need their own instructions for use?
Proposal 9(f). If you think other changes are needed for AUS Essential Principle 13.1, please explain.