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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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Conformity assessment procedures for each class of IVD

The conformity assessment procedures, including Australian declaration of conformity requirements, are detailed in Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).

Depending on the classification of a device, there are a number of different conformity assessment procedures a manufacturer may use to demonstrate compliance with the Essential Principles. Generally, the conformity assessment procedure is more rigorous the higher the risk class. The table below summarises the conformity assessment procedures most likely to be used for each class of IVD based on TGA experience with equivalent classes of medical devices (other than IVDs). Manufacturers may choose to complete procedures that are more comprehensive than the minimum, but this is not required by the TGA. The table also indicates the relevant clause of Schedule 3 describing which Australian declaration of conformity is appropriate for each option.

Class of IVD Conformity assessment procedures most likely to be used Declaration of conformity legislative reference
Class 1 IVD Part 6 (Declaration of Conformity Procedures Not Requiring Assessment by the Secretary) Schedule 3, Part 6, clause 6.6
Class 2 IVD Part 1 (Full Quality Assurance Procedures) excluding clause 1.6 (Examination of Design); or Schedule 3, Part 1, clause 1.8

Part 6 (Declaration of Conformity Procedures Not Requiring Assessment by the Secretary) +

Part 4 (Production Quality Assurance Procedures)

Schedule 3, Part 6, clause 6.6
Class 3 IVD Part 1 (Full Quality Assurance Procedures) excluding clause 1.6 (Examination of Design) Schedule 3, Part 1, clause 1.8

Class 4 IVD

&

Class 4 in-house IVDs

Part 1 (Full Quality Assurance Procedures) including clause 1.6 (Examination of Design) Schedule 3, Part 1 clause 1.8
Class 1–3 in-house IVDs Part 6A (Procedures applying only to certain classes of in-house IVDs) Not required
Systems or Procedure Packs Part 7 (Procedures for medical devices used for a special purpose) Schedule 3, Part 7, clause 7.5

Application of the procedures under Part 2 (Type Examination) is generally more costly for manufacturers, but is an option that can be considered for Class 3 and Class 4 IVDs and Class 4 in-house IVDs, in conjunction with Part 4 (Production Quality Assurance Procedures).

Conformity assessment procedures under Part 3 (Verification) and Part 5 (Product Quality Assurance) cannot be applied to IVD medical devices.

More information on relevant conformity assessment options is provided in the next table.

Summary of Australian conformity assessment procedures

Part Requirements Applicable classifications Considerations for manufacturer
Part 1 - Full quality assurance procedure - encompassing design, production, packaging, labelling and final inspection of an IVD

Manufacturer must implement a full quality management system (i.e. all clauses of ISO 13485 including clauses 7.3 and 7.5.2) and arrange for the quality management system to be audited by an appropriate conformity assessment body.

See under heading Manufacturer's evidence accepted by the TGA in Section What a sponsor needs to know about conformity assessment and manufacturer's evidence for IVDs

All except Class 1, 2 and 3 in-house IVDs

Please note: for Class 4 IVDs and Class 4 in-house IVDs, Clause 1.6 - Examination of design - must also be applied

Assessment can cover a wide range of devices - not limited to a specific device.

If the conformity assessment procedure is applied to all devices manufactured, new devices that are Class 2 or 3 IVDs that fit into the scope of the certificate should not require additional assessment/s by the conformity assessment body.

For Class 4 IVDs and Class 4 in-house IVDs, and Australian manufacturers of Class 2 and Class 3 IVDs, assessment by the TGA is required.

The quality management system must be maintained.

Periodic surveillance audits will be performed by the conformity assessment body.

Part 1, Clause 1.6 - Examination of Design - involves an examination of the design dossier for IVDs to which the manufacturer has applied a Part 1 conformity assessment procedure The technical documentation for the Class 4 IVD and Class 4 in-house IVD (also referred to as a design dossier) must be submitted for examination by the TGA to assess compliance with the Essential Principles. Class 4 IVDs and Class 4 in-house IVDs

A separate certificate is required for each kind of medical device that is a Class 4 or Class 4 in-house IVD within the meaning of section 41BE of the Therapeutic Goods Act 1989 and Regulation 1.6 - see Kinds of IVD medical devices in the Section Including IVD medical devices in the ARTG.

This must be done in conjunction with Part 1 assessment of the quality management system by the TGA. If a Part 1 certificate issued by the TGA is current, depending on the scope of the changes required for the new kind of Class 4 IVD, no further assessment of the quality management system may be needed.

Part 2 - Type examination - involves an examination of a representative sample of a kind of IVD (the type).

Testing can be conducted by the TGA or EU Notified Body; OR

The TGA or EU Notified Body can conduct tests on the device at the manufacturer's site and supervise or review the testing; OR

The TGA or EU Notified Body will subcontract the testing to an accredited test laboratory (either in Australia or overseas).

Class 3 and 4 IVDs and Class 4 in-house IVDs

Please note: Part 4 - Production Quality Assurance - must also be applied

Only applies to a specific IVD (type).

If substantial changes are made to the design or intended performance of the IVD, the manufacturer must notify the TGA and arrange for re-examination of the type.

Certification of the quality management system for production quality assurance under Part 4 must be maintained.

For Class 4 IVDs and Class 4 in-house IVDs, and Australian manufacturers of Class 3 IVDs, assessment by the TGA is required.

Part 4 - Production quality assurance - a quality management system encompassing the production and final inspection of an IVD

Manufacturer must implement a quality management system (i.e. all clauses of ISO 13485 excluding design and development - clause 7.3) and arrange for the quality management system to be audited by an appropriate conformity assessment body.

See under heading Manufacturer's evidence accepted by the TGA in Section What a sponsor needs to know about conformity assessment and manufacturer's evidence for IVDs for further details.

Class 2, 3 and 4 IVDs and Class 4 in-house IVDs

Please note: Part 2 - Type examination - must also be applied to Class 3 and 4 IVDs and Class 4 in-house IVDs

Assessment can cover a wide range of devices - not limited to a specific device.

For Class 2 IVDs this only covers production - the design of each device still requires Part 6 (Declaration of Conformity).

For Class 3 and 4 IVDs and Class 4 in-house IVDs medical devices this only covers production - the design of each device still requires conformity assessment under Part 2 (Type Examination).

For Class 4 IVDs and Class 4 in-house IVDs assessment by the TGA is required.

The quality management system must be maintained.

Periodic surveillance audits will be performed by the conformity assessment body.

Part 6 - Declaration of Conformity (not requiring assessment by Secretary) - preparing technical documentation for an IVD and establish a post-market monitoring system Manufacturer ensures that the devices comply with the Essential Principles and prepares documentation that demonstrates conformity. Class 1 and Class 2 IVDs

For Class 1 IVDs the evidence (Declaration of Conformity) is not required to be submitted to the TGA but MUST be available upon request.

For Class 2 IVDs Part 4 (Production Quality Assurance) is also required.

Part 6A - Procedures applying only to certain classes of in-house IVDs Laboratories (or laboratory networks) manufacturing in-house IVDs will be required to notify the TGA of the IVDs manufactured in each laboratory for inclusion on a database. Such laboratories must be accredited as medical testing laboratories by NATA or by a conformity assessment body determined by the Secretary, and demonstrate compliance with the National Pathology Accreditation Advisory Committee (NPAAC) performance standard for development and use of in-house IVDs.

Class 1, 2 and 3 in-house IVDs

Please note: Part 6A does not apply to Class 4 in-house IVDs

Laboratories must implement a quality management system that is accredited to ISO 15189 - Medical laboratories - Particular requirements for quality and competence.

Laboratories must notify the TGA of the in-house IVDs manufactured annually.

Class 4 in-house IVDs are subject to the same conformity assessment procedures required for commercial Class 4 IVDs.

For more information please see Section - In-house IVDs

Part 7 - Conformity Assessment Procedures for devices used for a Special Purpose Clause 7.5 applies to system or procedure packs All, except Class 1,2 and 3 in-house IVDs For systems and procedure packs see Section - Systems and Procedure packs.
Part 8 - Clinical Evaluation procedures The conformity assessment procedures the manufacturer must follow for obtaining and evaluating clinical data. All See Section - Essential Principles -14 Clinical Evidence

Please note: Conformity assessment procedures under Part 3 and Part 5 cannot be used for IVDs.

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