Systems or procedure packs: Declarations under Schedule 3 Part 7.5

Declarations to Schedule 3 Part 7.5 of the Therapeutic Goods (Medical Devices) Regulations 2002

13 May 2010

The following information relating to the supply of systems or procedure packs in Australia using declarations according to Schedule 3 Part 7.5 of the Therapeutic Goods (Medical Devices) Regulations 2002 has been developed jointly by the Medical Technology Association of Australia and the Therapeutic Goods Administration.

The information has been prepared to further clarify a number of particular issues which could be of relevance to some companies assembling procedure packs for supply in Australia.

The sections numbered from 1 to 4 below are implications relating to parts of a Schedule 3 Part 7.5 declaration. In each case the relevant section of the Part 7.5 declaration is provided followed by information about that requirement.

It should be noted that this information is guidance only and if any further clarification is required the TGA can be contacted. Companies are also advised to seek their own legal advice in terms of making applications or regulatory decisions.

1 Conformity assessment evidence is needed for components of systems or procedure packs

7.5(2) The declaration must:...

  • (e) state that the manufacturer has evidence:
    • (i) that the relevant conformity assessment procedures have been applied to each medical device in the package; and...

Comment:

Conformity assessment evidence is required to be held by the system or procedure pack assembler for all components that are medical devices in the system or procedure pack. This applies for all classifications of medical devices. This means that in addition to the Australian Declaration of Conformity, manufacturers of procedure packs that are classified higher than Class I would need to hold appropriate TGA, MRA or CE certification for the components.

2 Components of systems or procedure packs need to comply with the applicable essential principles

7.5(2) The declaration must:...

  • (e) state that the manufacturer has evidence:
    • (ii) that each medical device in the package complies with the applicable provisions of the essential principles; and...

Comment:

  1. Each medical device in the system or procedure pack needs to be presented in the form for which the certification was issued; ie presented in the system or procedure pack in the component manufacturer's packaging along with any relevant instructions for use (IFUs) from that manufacturer.
  2. This also means that the manufacturer of each component in the system or procedure pack can be identified from the information on the packaging for each component.
  3. If components of the system or procedure pack are not in the original packaging along with any relevant IFUs, the system or procedure pack assembler will then be considered as a manufacturer of the components and so if the procedure pack assembler wants to continue to use a Part 7.5 declaration, they will need to apply an appropriate conformity assessment procedure to those individual components. For Class I components a declaration of conformity will be required but for higher classifications conformity assessment certification will also be required.

    NOTE: If components of a system or procedure pack were not in their original packaging, and the system or procedure pack assembler does not want to use a Schedule 3 Part 7.5 declaration described in 2(c) above, the assembler must apply conformity assessment procedures to the complete system or procedure pack. This would then mean that in addition to the Australian Declaration of Conformity, systems or procedure packs classified higher than Class I would need appropriate conformity assessment certification.

3 The provision of Instructions for Use for components

7.5(2) The declaration must:...

  • (i) state that the information supplied with the system or procedure pack for the use of the system or procedure pack includes instructions for use provided by the manufacturer of each item in the package; and...

Comment:

  1. If the system or procedure pack assembler modifies the original manufacturer's IFU, either in content or format, such as reprinting, for any of the component devices then the assembler will be considered to have performed a manufacturing step, as per s41BG of the Therapeutic Goods Act 1989. They are then considered to have assumed responsibility for that component as the manufacturer and therefore must apply a conformity assessment procedure to that component. If the component was classified higher than Class I this would also require appropriate conformity assessment certification.

    Changing the component manufacturer's IFU is considered to be the same as taking an existing medical device and altering it in a way that was not intended by the original manufacturer.
  2. An IFU for each component of the system or procedure pack must be supplied with each system or procedure pack; not just to each customer who uses the system or procedure pack. The IFUs do not have to be physically included inside packs but they do have to be supplied with the pack in a way that the user of the pack can access them as attached to the outside of the pack, for example.

4 Statements concerning mutual compatibility of components

7.5(2) The declaration must:...

  • (h) state:
    • (i) that the mutual compatibility of each medical device, medicine or other therapeutic goods, and any other goods, in the package has been verified in accordance with any instructions for use provided by the manufacturer of each item or the approved indications for use of each item; and
    • (ii) that the manufacturer has manufactured the system or procedure pack in accordance with those instructions (if any) or indications; and

Comment:

Documentary evidence is expected to be produced by the system or procedure pack assembler that explains how they verified the mutual compatibility of the components of the system or procedure pack. It is not sufficient for the assembler to state that their customer has requested the combination of components and therefore the components must be mutually compatible.

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