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

Closes 13 Nov 2024

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Proposal 6: Amend AUS Essential Principle 11 – Protection against radiation

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

Proposal 6(a). Do you agree with the proposals to adopt the intent of the EU GSPRs, related to AUS Essential Principle 11?

This question and answer options only relate to the alignment with the EU GSPRs. Question 6(b) will consider your response to the AUS-specific clauses proposed.

More information

AUS Essential Principle 11 - Protection against radiation
AUS EP Reference Related EU GSPR Proposed changes 

EP 11.1

MDR GSPR 16.1

IVDR GSPR 15.1

For all devices:

  • Clarify that reducing exposure to radiation includes intended, unintended, stray or scattered radiation.

The remaining requirements of EP 11.1 are considered equivalent to the intent of the EU clauses.

EP 11.2

MDR GSPR 16.2

IVDR GSPR 15.2

 

For non-IVD devices:

  • Clarify that the visual indicator and/or audible warning referred to in Clause (4) are to apply, if practicable, when the device is in operation and emitting radiation
  • Clarify the intent of EP 11.2(3) is equivalent to MDR GSPR 16.2(a), that devices are to provide reproducibility of relevant variable parameters within an acceptable tolerance.

The existing EP 11.2(3) was unclear, and we are proposing to re-worded for clarity. No additional requirements.

For all devices:

  • Amend the wording “visible radiation” and “invisible” radiation to “ionising radiation” and “non-ionising” radiation.

The proposed amended terminology will provide consistency with other National Regulations on radiation safety and the EU Regulations.

EP 11.4

 

MDR GSPR 16.1(b) 

IVDR GSPR  15.3

 

For all devices:

  • To require information in the instructions for use on acceptance and performance testing, acceptance criteria and maintenance procedures.

This may also, or alternatively, be included under Essential Principle 13, depending on legislative structure.

NEW
11.5(2)

MDR GSPR 16.4(b)

 

For non-IVD devices:

  • Require radiation to be monitored during treatment, where possible.

11.5(3)

MDR GSPR 16.4(c) 

For non-IVD devices:

  • Clarify that part (b) of AUS EP 11.5(3) applies to both patients and users (changed from “patients or users”).

 

MATRIX response option

Please clarify your response to individual proposals below.
Proposal 6(b). AUS-specific clarification: Do you agree that AUS Essential Principle 11 should re-iterate requirements from AUS Essential Principles 7, 9, 12 and 13?

More information

Our intent is to increase clarity for manufacturers on the regulatory expectations that apply to devices that emit radiation.

For all devices:

  • Clarity that any waste products are disposed of appropriately, as required under proposals for AUS Essential Principle 9.
  • Reiterate the requirements of AUS Essential Principle 7.5, for manufacturers to minimise risks associated with leaching, such as unintended radiation when in operation and any leakage of radiation when not in operation.
  • Reiterate the requirements of AUS Essential Principle 13.4(3) Item 22, that manufacturers must inform users and patients of any warnings, precautions, contraindications and measures to be taken in the event of a malfunction of the device or changes in its performance that may affect safety. 

For non-IVD devices:

  • Reiterate the requirements of AUS Essential Principle 12.12, Protection against risks associated with administration of energy or substances, must be applied to devices that emit radiation.

MATRIX response option

Please clarify your response to individual proposals below.
Proposal 6(c). If you think other changes are needed for AUS Essential Principle 11, please explain.