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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs

Version 1.0, November 2011

24 November 2011

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Declaration of conformity

Once the relevant conformity assessment evidence has been obtained, the manufacturer of an IVD is required to make an Australian Declaration of Conformity which declares that the device complies with:

  • the applicable provisions of the Essential Principles
  • the classification rules
  • the conformity assessment procedures.

The declaration also requires the manufacturer to provide details that are relevant to the conformity assessment procedure and the manufacture of the IVD covered by the declaration. These details include:

  • manufacturer's name and address
  • details of the:
    • scope of the declaration (including product identification information)
    • certification
    • classification
    • nomenclature code
    • conformity assessment standards (quality management standards)

The responsibility for the classification and the conformity assessment of an IVD rests with the manufacturer of the IVD. The choice of an appropriate conformity assessment procedure, which will be governed by the class of the IVD, is also the responsibility of the manufacturer.

The wording of the Declaration of Conformity will depend on the conformity assessment procedure chosen by the manufacturer.

Templates for preparing draft Declarations of Conformity under each of the 4 different conformity assessment procedures pertaining to IVDs, as set out under Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002, are available on the TGA website at Declaration of conformity templates (IVDs).

The Declaration of Conformity can be signed and dated by the manufacturer of the IVD or a person authorised by the manufacturer. The declaration must set out the name and position of the person signing the declaration.

If requested, the sponsor or manufacturer must provide the TGA with a copy of the Declaration of Conformity.

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