Clinical evidence guidelines: Medical devices
The Clinical Evidence Guidelines for medical devices are intended to provide guidance to manufacturers of medical devices (including In vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence. While this guideline refers to IVDs, it is acknowledged that the information provided at this point is incomplete.
Sections of this guidance provide specific information on the clinical evidence requirements for the following types of devices:
- Total and partial joint prostheses
- Cardiovascular devices to promote patency or functional flow
- Implantable pulse generators
- Heart valve prostheses
- Supportive devices - meshes, patches and tissue adhesives
- There is also a specific section (Section 10) on implantable medical devices in the magnetic resonance environment.
Why (and when) clinical evidence is required
To provide confidence in the Australian healthcare system and to help ensure the health of the Australian population, all medical devices supplied in Australia must have clinical evidence sufficient to demonstrate an appropriate level of safety and performance when used for the intended purpose(s). Medical devices supplied in Australia must also be included on the Australian Register of Therapeutic Goods (ARTG) (unless exempt or excluded1).
Clinical evidence is not only required when a medical device is first included on the ARTG, but for the entire period it remains on the register. The TGA may request and review this clinical evidence at any time. Clinical evidence is frequently requested when there is an application for inclusion of a device on the ARTG, a review of conformity assessment procedures or when a safety issue with a medical device has been identified. The clinical evidence requirements described in this guidance apply in all these instances.
Broadly speaking, clinical evidence should provide a clinical assessor with a current and accurate picture of the state of scientific knowledge in relation to the treatment modality in general to which a device relates, and then with respect to the particular device specifically. From this information, an acceptable risk or safety profile is demonstrated for a medical device, by showing that it performs as intended and that all identified undesirable effects and hazards, having been minimised during the development process, are outweighed by the benefits. The detail and extent of the clinical evidence will depend on the classification of the device, its nature or design and the purpose(s) for which it is intended. This clinical evidence should be updated and systematically reviewed periodically as new information based on post-market surveillance activities and product experience becomes available.
Development of these guidelines
The TGA has developed this document in conjunction with the Royal Australasian College of Surgeons Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S) to supplement guidance on medical device regulatory requirements in the Australian Regulatory Guidelines for Medical Devices (ARGMD) 2.
These guidelines have been developed taking into account requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. They reference and align with international guidance documents including those of the Global Harmonization Task Force (GHTF) and the European Commission 'MEDDEVs' which are also based on the GHTF guidelines. The GHTF no longer exists, and has been permanently replaced by the International Medical Device Regulators Forum (IMDRF).
The literature search method used by ASERNIP-S to collect and collate the information referenced in this guidance is described in Appendix 3. This is subject to the limitations of the method, and it should be read and relied upon with this in mind.