Conformity assessment and summary technical reports for Class III medical devices

17 June 2014

This guidance is intended for applicants (the sponsors) seeking ARTG inclusion for Class III medical devices that are of a lower classification in Europe.

What happens when Class III device has a lower classification in Europe

Where medical devices that are Class III in Australia have a lower classification in Europe (such as Class IIa or IIb), the manufacturer may not have conformity assessment certification appropriate for a Class III medical device.

However, if the sponsor wishes to apply for ARTG inclusion of one of such devices in Australia, the manufacturer of the device would need to apply conformity assessment procedures appropriate for a Class III device and obtain the documentation demonstrating application of such procedure. Options available to manufacturers are to obtain:

  1. TGA conformity assessment certification in accordance with the Therapeutic Goods (Medical Devices) Regulations 2002 :
    1. Full Quality Assurance Procedures including Design Examination (Part 1 of Schedule 3 including clause 1.6); or
    2. Type Examination Procedures (Part 2 of Schedule 3) and:
      1. Verification Procedures (Part 3 of Schedule 3) (this does not apply to the devices that are intended to be supplied in a sterile state); or
      2. Production Quality Assurance Procedures (Part 4 of Schedule 3).
    3. OR
  2. EC conformity assessment certification in accordance with European Council Directive 93/42/EEC:
    1. EC Type-Examination Certificate issued in accordance with Annex III coupled with:
      1. EC Verification set out in Annex IV (this does not apply to the devices that are intended to be supplied in a sterile state); or
      2. EC Production Quality Assurance set out in Annex V.

Interim solution where all appropriate certification is not available:

Where the manufacturer presently has only an EC Certificate for the Full Quality Assurance Procedures issued under Annex II, excluding section 4, the manufacturer may seek a summary technical report from the Notified Body in lieu of the Design Examination certificate on the basis of the examination of the kind of device made under the requirements of Council Directive 93/42/EEC, Annex II, Section 4.

If the manufacturer does not currently hold an EC certificate for the Full Quality Assurance Procedures, they will need to obtain this first.

Where the manufacturer obtained the appropriate summary technical report for the kind of device, the sponsor can submit an application for ARTG inclusion of this device and provide the summary technical report in lieu of the design examination certificate as an interim arrangement.

If a decision is made to include the kind of device in the ARTG, this decision will be subject to a condition imposed on the ARTG inclusion.

What information needs to be in a summary technical report

Summary technical reports need to:

  • Demonstrate that the European Notified Body has assessed the device and determined it met all the relevant essential requirements of the European Council Directive 93/42/EEC, Annex II, Section 4 (design examination).
  • Impose all the obligations on the manufacturer, that would apply in relation to the requirements set out under the conformity assessment procedures for Class III medical devices, including:
    • manufacturer will allow the notified body to conduct surveillance inspections
    • manufacturer will allow the notified body to review the design of the device
    • manufacturer will notify the notified body of substantial changes to the design of the device
    • any other conditions that the notified body would have considered appropriate for inclusion on the EC design examination certificate, had it issued such a certificate.

If this is information is not evident from the report itself, you can provide a supplementary letter from the Notified Body.

Other documentation required

Before a sponsor submits an application for ARTG inclusion, they must lodge and get approved an appropriate certificate for the Full Quality Assurance procedure (issued in accordance with Annex II, excluding section 4) for the kind of device as a Manufacturer Evidence.

When a sponsor submits an application for ARTG inclusion of a Class III medical device in relation to which TGA has not issued conformity assessment certificate, TGA must select such an application for audit. When the application is selected for audit, the sponsor will be requested to provide information that is relevant to the audit, including (but may not be limited to):

  • evidence of the application of appropriate conformity assessment procedure to the kind of device (including the manufacturer's declaration of conformity made in accordance with Schedule 3 of the Regulations and appropriate certification);
  • information provided with the device (including labeling, instructions for use, brochures, surgical techniques, and other advertising material if relevant);
  • Clinical evidence and Risk Management Report; and
  • Technical documentation that demonstrates mechanism of action of the device where required.

The conditions imposed on your ARTG inclusion when you submit a summary technical report

If you submit a summary technical report in lieu of a design examination certificate together with the application for inclusion of a Class III device on the ARTG, any positive decision will be subject to imposing an additional condition on the ARTG inclusion. This condition will include requirements that the sponsor will provide within 12 months after the date of commencement of the ARTG inclusion:

  • appropriate Design Examination or Type-Examination certificate (whether from TGA or EC Certificate) for the kind of device; or
  • sufficient evidence that the assessment of the application for the design examination certificate of the kind of device has commenced (respective application has been submitted by the manufacturer to either TGA or a Notified Body no later than 6 months after the date of ARTG inclusion).

For applications for reclassification of partial hip, knee and shoulder joint implants in accordance with Part 11 of the Regulations, similar rule as specified above will apply.

Note: If you do not comply with the condition of the inclusion within the specified timeframe, the ARTG entry may be cancelled.

Further support

Contact the TGA on devices@tga.gov.au or call 1800 141 144 to talk to our friendly team.