When is a declaration of conformity required? On obtaining the necessary conformity evidence for their IVD medical device, an IVD medical device manufacturer must prepare an Australian Declaration of Conformity which declares that the device complies with the:
- Essential Principles
- Classification rules
- Conformity assessment procedures
In the Australian Declaration of Conformity, the manufacturer must provide details that are relevant to the conformity assessment procedure that has been applied for the IVD medical device. These details include:
- Manufacturer’s name and address
- Details of the
- Scope of the declaration
- GMDN Code
- Conformity assessment standards
In the past, the same template has been used for both medical devices and IVDs, depending on the conformity assessment route that has been taken. With the transition to the new IVD regulatory framework, the new templates are specific to IVDs and refer to details that are IVD specific, such the GMDN Collective term and code, reference to specific requirements for in-house IVDs etc. In this, the TGA templates for Declaration of Conformity are far more comprehensive than those used by IVD medical device manufacturers for the European market. Hence it is certainly worth paying attention when completing the Australian DOC to ensure that the details have been captured correctly and most importantly, ensuring that you have chosen the correct template for your device.
There are 5 templates that TGA has released, depending on the conformity assessment route taken and the classification of the device, as listed below:
- Class 4 in-house IVD medical devices: Declaration made under Clause 6B.6 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. This is the alternate conformity assessment procedure that has been introduced for Class 4 in-house IVDs.
- Full Quality Assurance procedure: Declaration made in accordance with the requirements of Clause 1.8 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. Full Quality Management System Certificate can be:
- TGA issued Conformity Assessment Certificate – Full Quality Assurance
- Overseas Certification – EU IVD Medical Devices Directive Annex IV
- ISO 13485: 2003 Certificate
- Production Quality Management System: Declaration made in accordance with the requirements of Clause 4.7 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002 for Class 3 IVD, Class 4 IVD or Class 4 in-house IVD.
- Declaration of Conformity in accordance to requirements of Clause 6.6 of Schedule 3, for Class 1 IVD, Class 2 IVD or Class 1 Export only IVD.
- Declaration of Conformity made under Clause 7.5 of Schedule 3 of the Regulations for Systems or Procedure Packs containing IVD Medical Devices.
It is vital that the correct template is chosen based on the classification of the device and the conformity assessment route taken.
The Declaration of Conformity can be signed and dated by the manufacturer of the IVD or a person authorized by the manufacturer. The declaration must set out the name and position of the person signing the declaration.
The new templates certainly align with the new IVD regulatory framework.