[Intro]
If you are performing a clinical evaluation for a device with limited clinical data or direct clinical use, you might consider an alternative approach for demonstrating adequate performance and safety. The MDR Article 61, Section 10 outlines what can be done for devices for which clinical data is not deemed appropriate.
However, just because there is a lack of clinical literature or data on a device, it does not mean you can simply claim Article 61 (10) for conformity. It is important to justify that your device should not rely on clinical data for evaluation. Instead, I will outline the criteria that we have used with our clients to determine whether Article 61 (10) is appropriate, and you can use to determine whether this is the best route for your device.
The first thing you want to consider is the risk class of the device. If your device is a CLASS III or implantable device, it cannot apply for Article 61 (10). However, if your device is CLASS I or CLASS II and non-implantable, it might satisfy this requirement.
Next you need to consider how your device interacts with the human body. Ideally, you can demonstrate that it interacts very minimally or not at all with the human body. Again, if it’s implanted or used in the body for a noticeable length of time, then the non-clinical route of conformity may not be possible. There is allowance for patient contacting devices such as basic surgical instruments, but you have to justify the duration, how established and accepted the design is, and the device’s role in the performance of the overall medical procedure. For example, scissors and forceps might be applicable, but a simple surgical tool that is critical to the success of an implanted device may not be applicable.
Next, you need to specify the intended clinical performance and how it can be assessed. Defining the intended use of the device is useful here. In many cases, Article 61 (10) devices have many potential uses and defining the broad scope of their clinical use may be difficult, so having a broad intended use statement is crucial.
It is common to have Article 61 (10) devices used as accessories in a procedure, where the clinical performance of the procedure is driven by a different primary device. For example, in clinical literature, there may be an angiography procedure that will generally report on the catheter and guidewire used, but not on the stopcock or tubing that is used. Therefore, clinical literature is not an appropriate data source, but other types of data can be appropriate.
Potential sources of appropriate data are listed here. If the device has a history on the market, you may include post market surveillance and vigilance data to demonstrate the performance and safety history of the device. You may also point to compliance to standards such as ISO standards or to non-clinical elements of commons specifications that are relevant to device performance and safety. Additionally, use any pre-clinical testing, bench testing, simulated testing, or animal testing data which comes from the design verification and validation of a device. Examples include studies related to mechanical characteristics, biocompability, or usability.
Note that post-market clinical follow-up, or PMCF, is sometimes (but not always) applicable for this route, as the point is to demonstrate that such clinical data is not appropriate for the evaluation of the device.
It is important to identify the available data sources and list them accordingly.
Finally, you need to look at the current marketing claims and audit them for any claims related to clinical benefit. There should be no direct clinical benefits or claims that could be considered to require clinical supporting data, derived from the use of the device. Claims that the device improves the health of patients or improves patient-relevant clinical outcomes will be considered as direct clinical benefits that require supporting clinical data.
Instead, you can highlight indirect clinical benefits that tie into the intended use of the device. Indirect clinical benefits include general use benefits or designs that are not explicitly meant to improve patient outcomes.
In conclusion, the criteria we recommend using when claiming Article 61 (10) conformity consists of the following four points. If your device satisfies the details in the criteria outlined here, then the Article 61 (10) route of conformity is an option to consider. That said, remember that you still need to provide a clinical evaluation assessment in the form of a clinical evaluation plan and report.
It is within the CEP and CER where we justify why the Article 61 (10) route is acceptable. We recommend that you specifically say that you are claiming Article 61 (10), that clinical data is not deemed appropriate, and to list each of these bullet points and provide your justification.
Furthermore, remember that you are still required to perform literature searches to identify whether the device is ‘state of the art’ and compare it to other benchmark devices. Also, you may find some clinical literature that is available, and you need to appraise these articles for potential risks or data you may not be aware of. Furthermore, you need to demonstrate your search, screening, and appraisal methodology. For legacy devices, any clinical literature and post market surveillance data will need to be assessed together.
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