The requirements for clinical evaluation and the significance of clinical data for medical devices have become greater as a result of the MDR – everyone knows that by now. But what does this mean for startups in the medtech sector? And what do you have to consider on your way to product approval?
Everyone in the medtech sector has noticed: The MDR places significantly higher requirements on the availability, collection and evaluation of clinical data on a medical device. The requirements for clinical evaluation have become more extensive and often there is no way around collecting your own clinical data to demonstrate safety and performance in the clinical evaluation, and thus for the conformity assessment. This means a clinical investigation with all its regulatory requirements must be conducted. The clinical benefit of a medical device has also gained in importance with the MDR. All this is fundamentally correct and desirable! Because I, as a potential user of a medical device, also want to know that the product I am using for my health works, is safe and has the desired effect. So, it is good that the clinical evaluation and ultimately the decision about market access of a medical device must be based on sufficient clinical evidence. This in turn means that sufficient clinical data from sources with sufficient clinical evidence must be available and evaluated before a medical device is allowed to carry the CE mark.
However, the MDR requirement for sufficient clinical evidence in the clinical evaluation and, if applicable, for own clinical data, with all the requirements for a clinical investigation, poses challenges for medical device manufacturers: What is sufficient evidence? What are the evidence requirements for demonstrating safety and performance, and what are the evidence requirements for demonstrating clinical benefit? Does a clinical investigation need to be conducted to generate the required data? Which study design is appropriate? There are no blanket answers! The answers logically depend on the product, its risk profile, the medical field of application including alternative therapy options, if any, the scope and availability of clinical data on comparator products, etc. But – of course – the higher the risk profile, the higher the requirements for proof of safety and clinical benefit. Because in the end, the benefit must be in positive proportion to the risk. In order to be able to carry out this weighing up, one must of course know both the benefit and the risk, on the basis of the (possibly own) clinical data on the product. So far, everything is logical and makes sense 😉
Art. 2 (44): “Clinical evaluation” means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
Art. 2 (45): “Clinical investigation” means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
But the MDR’s perfectly reasonable requirements for clinical data go hand in hand – as I said – with high regulatory, organizational and strategic challenges for medical device manufacturers. Sometimes this even means the end for an already established product.
However, young companies that are in the process of being established and do not yet have experienced “Regulatory Affairs” and “Clinical Affairs” departments have a particularly difficult time. The regulatory hurdles often mean that innovations do not even make it to the market. Especially in the medtech sector, startups often fail on the way from their innovative idea to market access. And this is not because their idea was a pipe dream without clinical relevance, but because the regulatory requirements imposed by the MDR are so extensive and high.
As a startup in the medtech industry, it is therefore essential to get involved with and plan the clinical evaluation process early on and in parallel with product development. The plan for the clinical evaluation must already be recorded in the so-called Clinical Evaluation Plan (CEP). This planning automatically raises the question of which of the basic safety and performance requirements require clinical data to show compliance. Once this has been clarified, it should be checked whether clinical data from comparator products already exist for these aspects (e.g. literature search via scientific publications) and, if so, whether these data are available. However, due to the stricter MDR requirements also with regard to the comparability of products (equivalence), it must be shown that a product is actually comparable in order to be able to use the data for the clinical evaluation. This is often not feasible due to lack of access to product-specific documents. But that is another topic, which would lead too far here.
It should be borne in mind that the properly conducted literature search and appraisal, including its planning and documentation, already represents an enormously large work package in the clinical evaluation process. If it turns out that there is not yet enough clinical data on one’s own product (or comparator product), which is to be assumed in the case of a novel, innovative product, a strategy must be worked out as to how the missing clinical data can be generated, which brings us to the topic of clinical study planning. The well-planned clinical study (clinical investigation) then in turn generates the missing clinical data for the clinical evaluation process, closing the gap for safety and performance evidence. But be warned, the clinical investigation is arguably the largest work package on the road to CE marking and should not be underestimated in terms of the time and money involved. Once the clinical data are finally available, all activities and the results of the clinical evaluation process must of course still be documented and evaluated in a report. The clinical evaluation report (CER) is a comprehensive document that concludes with a risk-benefit assessment and a conclusion. That’s how it basically works!
- Plan your clinical evaluation process early
- Check out which clinical data are required to demonstrate safety and performance of your device
- Draft a strategy on how to generate the required data
- Plan your clinical study (if applicable) early and carefully
- Hang in there!
With my work as a startup coach, I can of course not break down the mentioned hurdles. BUT I can train you as startups accordingly – e.g., by pre-assessing your clinical study plan or with templates for the clinical evaluation –, so that you can overcome the hurdles with the appropriate strength and endurance.