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

EP 8.1

MDR GSPR 11.1

IVDR GSPR 11.1

For all devices:

• Clarify the intent that, where applicable, the risks of unintended cuts and pricks is to be minimised
• Require devices to be designed to allow safe handling.

NOTE: The intent of MDR (c) and IVDR (b) are already aligned with AUS Essential Principle 8.1(c)
The intent of MDR (d) and of IVDR (c) are already aligned with AUS Essential Principle 8.1(b).

NEW
EP 8.2

.

MDR GSPR 13.2

IVDR GSPR 12

For non-IVD devices:

• Extend the application of the "Note", in AUS EP 8.2(5), which currently only applies to “certain IVD medical devices”, to also apply to “certain medical devices” (i.e to apply to both IVD and non-IVD devices)
• Where devices utilise tissues or cells of animal origin or their derivatives, manufacturers are to include within their risk management system, a strategy to prevent transmission of animal-borne diseases, such as but not limited to, spongiform encephalopathies.

NOTE: The above requirement aligns with a similar requirement in the referenced  Regulation (EU) No 722/2012:

1.2 Process of risk assessment:

“In order to ensure a high level of protection for patients and users, the manufacturer of devices utilising animal tissues or derivatives referred to in point 1.1 must implement an appropriate and well documented risk analysis and risk management strategy, to address all relevant aspects relating to TSE. He must identify the hazards and evaluate the risks associated with those tissues or derivatives, establish documentation on measures taken to minimise the risk of transmission and demonstrate the acceptability of the residual risk associated with the device utilising such tissues or derivatives, taking into account the intended use and the benefit of the device.”

For IVD devices:

• Expand the scope of AUS EP 8.2 to include IVD devices incorporating tissues, cells and substances of human origin, or their derivatives, which are non-viable or rendered non-viable.

The EU IVDR GSPR 12 is broader than the AUS EP 8.2, as it includes IVD devices that contain biological substances of human origin.

Our IVD devices framework does include devices which contain biological material of both animal and human origin that is non-viable or rendered non-viable, although this is not currently captured within our Essential Principles.

Any device that includes biological material that is viable is regulated as a biological under our Biologicals Regulatory Framework. 

NEW
(No equivalent)

MDR GSPR 13.3

For non-IVD devices:

• To include devices containing non-human and non-animal substances or their derivatives which are non-viable or rendered non-viable, not covered under AUS EP 8.2(1)(a, b)
• For non-human and non-animal substances that are non-viable or rendered non-viable, equivalent requirements to those already applied under AUS Essential Principle 8.2.

The EU MDR GSPR 13.3 is a catch-all clause to include anything other than substances from human or animal origin, which are non-viable or rendered non-viable. As such, we are proposing to introduce a similar “catch-all” clause. This may result in changes to where recombinant and microbial origin material are included but will not change the requirements for compliance.

NEW
(No equivalent)

MDR GSPR 11.2

For non-IVD devices: NEW

• Where necessary, devices are to be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation.

NEW
(No equivalent)

MDR GSPR 11.3

IVDR GSPR 11.2

For all devices:

• Introduce specific microbial state and requirements that the device be designed, produced and packed in a way to ensure that the device maintains its specific microbial state when it is supplied, stored and transported in accordance with the directions of the manufacturer, until the protective packaging is opened or damaged.

NEW
EP 8.3(1,2)

MDR GSPR 11.4

For non-IVD devices:

• Non-IVD devices supplied sterile are to ensure that the integrity of the packaging is clearly evident to the final user.

Only the last sentence of MDR GSPR 11.4 introduces a new requirement, the intent of the remaining requirement is already aligned.

NEW
EP 8.3(4)

MDR GSPR 11.6 & IVDR GSPR 11.4

For all devices:

• Manufacture of devices to be supplied sterile is to occur in appropriate and controlled facilities.

NEW
EP 8.5

MDR GSPR 11.8 & IVDR GSPR 11.6

For all devices:

• Extend the requirements for labelling of identical or similar devices, supplied both sterile and non-sterile, to be easily distinguished, in addition to the marking used to indicate the device is sterile.