Custom Devices, Clinical Trials and the Hazards of Precedent

02 September 2019 |


This past week an interesting post cropped up in the RAPS discussion board. An Australian member asked about doing clinical trials of custom-made medical devices.

A surgeon inventor wanted to do a clinical trial of a custom device manufactured by a third party, for publication and supporting future regulatory approval including TGA conformity assessment.

The overall question was: should an ethics committee approval be required? After all “We know cosmetic and plastic surgeons publish new methods all the time under the declaration of Helsinki, without a separate committee (like NHMRC) assessment.”

This honestly and openly stated question raises so many issues.

For starters – the ambition to obtain TGA assessment and registration is currently not available. Custom devices currently are exempt from entry onto the Australian Register of Therapeutic Goods. So, it’s currently not actually possible to obtain a direct TGA registration for a custom device, nor to apply for conformity assessment. There is a separate notification database where manufacturers of custom devices are required to notify TGA of their activities. But that does not constitute any kind of regulatory review or approval. There are some workarounds which involve things like putting a custom device in a kit and registering the kit, but they are contrived and probably won’t persist in the face of upcoming regulatory change.

TGA is actively looking at changing the regulations to require registration of some higher risk custom devices (e.g. implants). If this happens, registration and conformity assessment will be required. So it pays to follow what the regulators are doing and what may change.

But of particular interest is the insight into when a clinical trial is needed and what kind of oversight is required. Irrespective of registration, custom devices must still meet the Essential Principles and manufacturers are required to keep Technical Files showing safety and performance. There is some leeway for custom devices, in that TGA accepts they may be used in special circumstances and there may be some gaps in compliance which may be justified by risk-benefit comparisons, but that does need to be justified in the Technical File.

Now, if a clinician is contemplating a clinical trial, that implies there is an evaluation required of clinical performance. This, in turn, means that there is unknown compliance for the outcomes being assessed in the trial.

Therefore, a clinical trial approval should be obtained via an ethics committee and TGA notified of the trial under the Clinical Trials Notification (CTN) scheme. (there are equivalent requirements in Europe, USA and most established international regulatory systems.

And it’s vital to understand that if the data from the trial are to be used in a future regulatory approval (anywhere in the world), then a regulator will only recognise those data if there is evidence that the trial was properly approved and managed.

Having said all of this, there is widespread lack of understanding of these requirements and it’s not uncommon for custom devices to be manufactured and used with less than perfect documentation and evidence of compliance.

The lesson: always keep a weather eye on regulatory change and be very cautious when about relying on what others are doing as precedent.

If you are a RAPS member you can read the original discussion here.

If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)


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