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

MDR GSPR 23.4(a)
(Refers to 23.2(a))

IVDR GSPR 20.4.1(a)

For all devices:

• Include the name of the device.

Item 1

MDR GSPR 23.4(a)
(Refers to 23.2(c))

IVDR GSPR 20.4.1(ad)

For all devices:

• Clarify that the manufacturer’s address has to be their registered place of business. 

For IVD devices:

• Provide contact details for users to obtain technical assistance, including a telephone number and/or fax number and/or website address.

NEW
(No equivalent)

MDR GSPR 23.4(a)
(Refers to to 23.2(r) and 23.4(t))

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:
  • the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action
  • warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contraindications, undesirable side-effects and risks relating to overdose;

Item 2

MDR GSPR 23.4(u)

IVDR GSPR 20.4.1(c,e)

For all devices:

• Include indications and contra-indications, where applicable.

For IVD devices:

Note: Additional specific details from IVDR GSPR 20.4.1(c) are also being proposed for IVD devices under EP 13.3(4) Item 29.

Item 3

MDR GSPR 23.4(s)

For non-IVD devices:

• Inform the user and/or patient of any residual risks, where relevant.
• Provide information to allow the user to inform patients about any residual risks, where relevant.
• Examples to be included for clarity, such as: 
  • external electrical and electromagnetic effects
  • electrostatic discharge radiation associated with diagnostic or therapeutic procedures
  • pressure, humidity, or temperature.

Note: Remaining clauses of MDR 23.4(s) are under EP 13.4(3) Items 5, 22 and 24.

NEW
Item 4

For non-IVD devices:

• Where applicable, a specification of the clinical benefits expected.
• Where applicable, links to the summary of safety and clinical performance.
• The performance characteristics of the device.

For IVD devices:

Note: Relevant requirements will be included under Item 29 of EP 13.4(3).

NEW
Item 5

MDR GSPR 23.4(g,s)

IVDR GSPR 20.4.1(n(iii,iv))

For all devices:

• Inform the user and/or patient of any residual risks, where relevant.
• Provide information to allow the user to inform patients about any residual risks.
• Include information that allows the user and/or patient to be informed of any warnings, precautions, contraindications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device.
• Include, where appropriate:
  • warnings, precautions and/or measures to be taken as regards the risks of interference, such as electromagnetic interference, emitted by the device affecting other equipment, posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or therapeutic treatment or other procedures.
  • precautions related to material incorporated into the device that that consist of carcinogenic, mutagenic or toxic to reproduction substances or endocrine disrupting substances.
  • precautions related to material incorporated into the device that could results in sensitisation or an allergic reaction.

Note: Remaining clauses of MDR GSPR 23.4(s) are under EP 13.4(3) Items 3, 22 and 24.

Remaining clauses of IVDR GSPR 20.4.1(n) are included under other Items in EP 13.4(3) as outlined below:
(i) – EP, Item 22
(ii) – EP, Item 3
(v) – EP, Item 8
(vi) – EP, Item 20

NEW
Item 8

MDR GSPR 23.4(a)
(Refers to 23.2(n), and 23.4(p))

& IVDR GSPR 20.4.1(n(v))

For non-IVD devices for single-use:

• Include information characteristics and technical factors that could pose a risk if the device were to be re-used.
• Provide information is to be based on sufficiently detailed information in the manufacturer's risk management documentation.
• If no instructions for use are required with the device the information is to be made available to the user upon request.

Item 12

MDR GSPR 23.4(l) & IVDR 20.4.1(m)

For all devices supplied sterile:

• If the device is supplied sterile, include instructions in the event of the sterile packaging being unintentionally opened or damaged before use.

Item 13

MDR GSPR 23.4(m) & IVDR GSPR 20.4.1(r)

For IVD devices:

• For IVD devices intended to be sterilised before use include information, where relevant, of any preparatory treatment or handling of the device needed before it is ready for use.

Item 15

MDR GSPR 23.4(k) & IVDR GSPR 20.4.1(s)

For all devices:

• Include any limitation on the use of calibrators and controls, such as if they are suitable for a dedicated instrument only.
• Include methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices.

Item 16

MDR GSPR 23.4(k)

IVDR GSPR 20.4.1(s)

For all devices:

• Include information on preparatory cleaning or disinfection, where relevant.

Item 17

MDR GSPR 23.4(i)

For non-IVD devices:

• Details of any preparatory treatment or handling of the device before or during use.
• Examples may be included, to provide additional clarity.

Item 18

MDR GSPR 23.4(q)

IVDR GSPR 20.4.1(j)

For all devices:

For devices installed with or connected to other equipment:

• Include information on any known restrictions to combinations of devices and equipment.

Item 19

MDR GSPR 23.4(u)

For non-IVD devices that are implantable:

• Include qualitative and quantitative information on the materials and substances to which patients can be exposed.

Item 20

MDR GSPR 23.4(n)

IVDR GSPR 20.4.1(n(vi))

For all devices that are reusable:

• Require re-sterilisation methods provided with the device to be validated methods.
• Include information to allow users to know when a device should no longer be used, with example/s.

Item 21

MDR GSPR 23.4(r)

For non-IVD devices intended to emit radiation for medical purposes:

• Include information on protection for the patient, user and other persons from unintended radiation during use of the device.

Item 22

MDR GSPR 23.4(s)

IVDR GSPR 20.4.1(n(i))

For non-IVD devices:

• Include information covering, where appropriate, warnings, precautions and/or measures to be taken in the event of malfunction of the device that may affect safety.

For IVD devices:

• Include information covering, where appropriate, warnings, precautions and/or measures to be taken in the event of malfunction of the device or its degradation as suggested by changes in its appearance that may affect performance.

Item 24

MDR GSPR 23.4(s)

For non-IVD devices incorporating medicinal products:

• The scope is to be expanded to also include biological products or substances to be administered.
• Information to be provided to also include any incompatibility in the choice of substances to be delivered or other necessary warnings or precautions.

Note: Requirements for devices incorporating any stable derivative of human blood or blood plasma, are under EP 13.4(3) Item 25

Requirements for devices incorporating tissues, tissue derivatives, cells or substances of animal origin that have been rendered non-viable, are under EP 13.4(3) Item 25A.

NEW
Item 26

MDR GSPR 23.4(v) 

IVDR GSPR 20.4.1(ac) 

Also from MDR GSPR 14.7 and IVDR GSPR 13.6

For all devices:

If there are risks associated with the disposal of the device, its accessories, consumables or waste products, where appropriate, include:

• warnings and precautions on the safe disposal of the device, its accessories, consumables used with it and any waste products, including:
  • infection or microbial hazards
  • physical hazards
  • environmental hazards
  • clarity provided through relevant examples
• identified and tested disposal procedures for the device, and any related waste products.*

*Note: MDR GSPR 14.7 and IVDR GSPR 13.6 both require that “manufacturers identify and test procedures and measures as a result of which their devices can be safely disposed of after use. Such procedures shall be described in the instructions for use.”

While the EU GSPRs do not explicitly list this requirement under their equivalent labelling GSPRs, we consider it important to include this requirement specifically under EP 13.

This is also addressed under our existing AUS Essential Principle 9.2(h), which requires devices to facilitate safe disposal of the device and waste products.

Item 27

MDR GSPR 23.4(h)

IVDR GSPR 20.4.1(w)

For non-IVD devcies:

Accuracy claims for devices with a measuring function:

• Require information to be included on specifications the user needs to use the device appropriately, such as, (but not limited to) devices with a measuring function, the degree of accuracy claimed for it.

For IVD devices: 

• Require information to be included on analytical performance characteristics, including analytical sensitivity, analytical specificity, trueness, precision, accuracy, limits of detection and measurement range, measuring range, linearity and information about the use of available reference measurement procedures and materials by the user.

NEW
(No equivalent)

MDR GSPR 23.4(f)

For non-IVD devices:

• Include information, where applicable, to allow healthcare professionals to:
  • verify if the device is suitable
  • select the corresponding software and accessories.

NEW
(No equivalent)

MDR GSPR 23.4(o)

For non-IVD devcies:

• Include information, if appropriate, on whether the device can be reused only if it is refurbished (as defined in Regulation 1.5^[1]) under the responsibility of the manufacturer to comply with the requirements of the AUS Essential Principles.
   

  ---

  [1] Therapeutic Goods (Medical Devices) Regulation 2002, Part 1.5 Refurbishment

NEW
(No equivalent)

MDR GSPR 23.4(w)

For non-IVD devcies:

• For devices intended for use by lay persons, include the circumstances in which the user should consult a healthcare professional.

For IVD device:

Note: This requirement also applies to IVD devices, and is re-iterated in AUS EP 13.4(3)29 under the NEW proposals for adoption from IVDR GSPR 20.4.2 (f).

NEW
(No equivalent)

MDR GSPR 23.4(y)

IVDR GSPR 20.4.1(ae)

For all devcies:

• Include the date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use.

Note: We do not propose to adopt the additional requirement of the IVDR GSPR 20.4.1(ae) to also include the additional requirement for a clear indication of the introduced modifications.

NEW
(No equivalent)

MDR GSPR 23.4(z)

IVDR GSPR(af)

For all devcies::

• Include information to inform users and/or patients about reporting adverse events.

NEW
(No equivalent)

MDR GSPR 23.4(ab)

IVDR GSPR 20.4.1(ah)

For non-IVD devcies:

• Include requirements necessary to operate devices that incorporate electronic programmable systems, including software, or software that are devices in themselves,  minimum requirements for hardware, IT network characteristics and IT.

For all devices:

• Include security measures, including protection against unauthorised access, necessary to run the software as intended.

Note: While these are new additions to AUS EP 13.4(3), they are not new requirements, as they are included under AUS EP 12.1 (also within MDR GSPR 17.4 & IVDR GSPR 16.4)