With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation reports (CERs). Once final, this guidance will be used in conjunction with the existing Australian Regulatory Guidelines for Medical Devices (ARGMD).
Clinical evidence for devices can vary depending on the class of the medical device. It is common for manufacturers to provide a CER derived from a variety of sources, such as clinical trials, literature reviews and/or post-market data for the proposed device. It is also common to collate data from equivalent or similar devices as long as there is an explanation of how evidence for the equivalent or similar device is applicable to the proposed device. Most of the time, literature reviews form a part of the CER.
The features of a literature review provided in this draft clinical evidence guideline closely resemble those for a literature-based submission (LBS) for medicines, such as:
- A documented methodology, which captures published and unpublished scientific literature, both favourable and unfavourable,
- A search protocol, which would include the database searched, search terms and limits used, inclusions/ exclusion criteria, to ensure the search can be replicated,
- A selection strategy, which involves examining the quality of the literature, including the design of the study/ investigation, quality and completeness of the data reported, its scientific impartiality, and validity of any conclusions drawn in the paper,
- Critical analysis of the data by an expert in the therapeutic area, rather than a summary of each literature article and a general conclusion at the end.
Some of the common errors made in CERs have also been highlighted by the TGA in this draft guideline. Errors tend to relate to the proposed literature search strategy, such as the lack of a comprehensive literature review with documented methodology, an inadequate demonstration of substantial equivalence between reference device and the device under review, absence of critique or discussion of the evidence or its validity.
There is no need to obtain prior TGA approval for the proposed search strategy, however based on the above criteria, the TGA will be expecting a CER that delivers strongly on the quality of data.
The TGA consultation for the draft clinical evidence guideline closes COB on 10 June 2016, so make sure you take a look and provide input where necessary.
For assistance developing a suitable CER for your product, please contact our expert Regulatory Services team on +61 3 9251 0777.
This article was written by Wai Zin Wong, from our Regulatory Service team.