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

EP 7.1

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MDR GSPR 10.1

IVDR GSPR 10.1

For non-IVD devices:

• Increase clarity on factors to be considered, related to choice of materials, by adopting the intent of the requirements in EU MDR GSPR 10.1 (a-h), with particular attention being paid to:

1. the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability;
2. the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;
3. the compatibility between the different parts of a device which consists of more than one implantable part;
4. the impact of processes on material properties;
5. where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;
6. the mechanical properties of the materials used, reflecting, where appropriate, matters such as strength, ductility, fracture resistance, wear resistance and fatigue resistance;
7. surface properties; and
8. the confirmation that the device meets any defined chemical and/or physical specifications

For IVD devices: 

• Provide clarity by including the details in IVDR GSPR 10.1 for which particular attention should be paid including, but not limited to, the possibility of impairment of analytical performance due to physical and/or chemical incompatibility between the materials used and the specimens, analyte or marker to be detected (such as biological tissues, cells, body fluids and micro-organisms), taking account of the intended purpose of the device.

EP 7.1

MDR GSPR 12.2

For non-IVD devices: 

• Provide clarity that for devices composed of substances, or of combinations of substances, that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body, that attention be paid to the evaluation of:
  • absorption
  • distribution
  • metabolism
  • excretion
  • local tolerance
  • toxicity
  • interaction with other devices, medicinal products or other substances
  • potential for adverse reactions.

NEW
EP 7.5

MDR GSPR 10.4.1

IVDR GSPR 10.3

For all devices:

• NEW: Expand the scope to include leaching of particles. 
• Clarify that leaching and release of substances includes wear debris, degradation products and processing residues, that may be released from the device.
• NEW: Special attention shall be given to minimising risks as far as possible associated leaking or leaching of:
  • substances which are known to be carcinogenic, mutagenic or toxic to reproduction (‘CMR’) and
  • substances which have endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health.

As Australia does not have the equivalent legislative framework as Europe regarding the requirements placed on CRM and/or endocrine-disrupting substances, we will at this stage, propose to take a broader principles-approach. This will be similar to that outlined in the IMDRF guidelines. As such, the specific requirements of EU MDR GSPR 10.4.1, 10.4.2 and 10.4.5 will not be adopted.

However, we may include in our guidance clarification on applying the principles of EP2 in minimising risks related to such substances. For example, it would be expected that for any substances known to be carcinogenic, mutagenic or toxic to reproduction, or endocrine-disrupting, the manufacturer would:

• • undertake an analysis and estimation of potential patient or user exposure to the substance
  • undertake an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives
  • be able to justify as to why possible substance and/ or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product; including taking into account if the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials.
  • Include precautions and warnings for any vulnerable populations for which the device is intended to be used

EP 7.5 & EP 7.6

For all devices:

• AUS Essential Principles 7.5 & 7.6 to be restructured so that the ingress requirements are within one clause and the requirements for egress and leaching are combined within a separate clause.