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As part of the conformity assessment procedures, the manufacturer of an IVD medical device is required to make a Declaration of Conformity which declares that the device complies with:
- the applicable provisions of the Essential Principles
- the classification rules
- an appropriate conformity assessment procedure
The declaration also requires the manufacturer to provide details that are relevant to the conformity assessment procedure and the manufacture of the IVD medical device covered by the declaration.
It should be noted that these templates are published to assist in the preparation of declarations of conformity. It is the responsibility of the manufacturer signing a declaration to ensure that it is drawn up correctly and meets all the legal requirements.
Clause 6B.6
Manufacturer's declaration of conformity - Class 4 in-house IVD medical devices - Clause 6B.6 (docx,135kb)
Declaration made under Clause 6B.6 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. If applying Full Quality Assurances procedures under Schedule 3, Part 1, use the alternative template below.
Clause 1.8
Manufacturer's declaration of conformity - full quality assurance procedure - Clause 1.8 (docx,126kb)
Declaration made in accordance with the requirements of Clause 1.8 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Clause 4.7
Template: Manufacturer's declaration of conformity - production quality management system - Clause 4.7 (docx,127kb)
Declaration made in accordance with the requirements of Clause 4.7 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Clause 6.6
Template: Manufacturer's declaration of conformity - Clause 6.6 (docx,125kb)
Declaration made in accordance with the requirements of Clause 6.6 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Template: Manufacturer's declaration of conformity for Class 1 IVD medical devices - Clause 6.6 (docx,130kb)
Declaration made in accordance with the requirements of Clause 6.6 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
For more see Guidance for Declaration of Conformity for Class 1 IVD medical devices.
Clause 7.5
Template: Manufacturer's Declaration of Conformity for Class I medical devices and Class 1 IVD system or procedure packs (docx,135kb)
Declaration made in accordance with the requirements of Clause 7.5 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Template: Manufacturer's Declaration of Conformity for system or procedure packs (other than Class I or Class 1 IVD system or procedure packs) (docx,42kb)
Declaration made in accordance with the requirements of Clause 7.5 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
For more see Guidance for Declaration of Conformity for Class 1 IVD medical devices.