So what’s new? Well in terms of requirements, nothing has changed. The key elements of Clinical Evaluation are still the same: collecting available data from clinical trials, literature and post-market data, and then conducting a risk analysis to determine the benefit: risk ratio and subjecting this to expert clinical review.
What the guidance does is detail how to conduct the clinical evaluation and how to present the data in your Clinical Evidence Report (CER). Clinical evidence is the leading cause of rejection of medical device registration submissions (and of removal of entries from the register following TGA postmarket audits)
Here are some of the key take-home messages from the guidelines:
- The CER must be reviewed and endorsed by a competent clinical expert. This must be someone with medical qualification and direct clinical experience relevant to the device. The CV of the clinical expert must be provided.
- The literature review must detail the search protocol, selection strategy and critical appraisal of the studies.
- Clinical data can be collected for the device itself, a predicate device or a similar marketed device.
- Risk analysis or risk assessment must be included. The risk analysis should include all risks identified in the clinical data collected.
- At a minimum, the CER should be updated every 1-5 years.
- For devices based on technologies with well-established safety and performance characteristics, the manufacturer can demonstrate compliance to relevant recognized standards.
- There are specific requirements for certain high risk devices. These include total and partial joint prostheses, cardiovascular devices to promote patency or functional flow, implantable pulse generators, heart valve replacements using a prosthetic valve and supportive devices such as Meshes, Patches and Tissue Adhesives.
- If claiming use in the Magnetic Resonance (MR) environment, clinical evidence must be provided to support MR compatibility.
A recommended structure of the CER is provided in the guidelines. The structure follows the GHTF document Clinical Evaluation SG5/N2R8:2007 and MEDDEV 2.7/1 revision 4.
The full document is 165 pages long and can downloaded here.
Need help with your Clinical Evidence Report? We have wide experience preparing, writing and critiquing Clinical Evidence Reports for a diverse range of products, from general hospital equipment to high-risk surgical and cardiovascular devices. Contact us now and we will show you how to develop a report to meet TGA expectations. Call our Sydney office on +61 2 9906 2984 or email firstname.lastname@example.org