Clinical Affairs
Clinical & Non-Clinical Evidence: Designed, Not Accumulated
Under the MDR, manufacturers face rising expectations for clinical evaluations and mounting pressure to justify when a clinical investigation is not required.
Most low- and medium-risk devices, especially those that are standard of care, can demonstrate safety and performance without a clinical investigation, if the evidence strategy is well designed from the start.
At Escentia, we specialise in integrated evidence strategies that combine clinical reasoning with non-clinical testing, human factors, and risk management. Our work helps you avoid unnecessary clinical investigations while building defensible, high-quality clinical evaluations that stand up to Notified Body review.
What We Do
Evidence Strategy (Our Core Service)
We design full-lifecycle evidence strategies that determine:
- what can be demonstrated non-clinically,
- what must be addressed in the clinical evaluation,
- and whether a clinical investigation is truly required.
This integrated approach reduces regulatory uncertainty and ensures that clinical reasoning is embedded into requirements engineering, risk controls, and V&V and not treated as an afterthought.
Our evidence strategy framework is informed by the ECliPSE research on defining the boundary between non-clinical and clinical evidence, ensuring our recommendations are scientifically grounded and proportionate.
Clinical Evaluation (CER, CEP)
We prepare clinical evaluations that are:
- scientifically rigorous
- methodologically transparent
- consistent with MDR and MEDDEV
- tightly linked to your risk management and performance claims
Manufacturers often ask whether literature and non-clinical data can replace new clinical data. In many cases, the answer is yes – but only when the argument is structured correctly.
Non-Clinical Evidence Pathways
Whenever possible, we help you answer safety and performance questions through:
- bench testing based on scientific evidence
- simulated use
- human factors engineering
- structured expert input
A strong non-clinical evidence package is the most effective way to avoid unnecessary clinical investigations and is often the only way to keep development timelines under control.
Targeted Clinical Data (Only When Needed)
If clinical data is genuinely required, we define the minimal, focused scope and work with trusted partners to execute efficient studies.
Our priority is always to ensure that clinical data generation is:
- justified,
- proportionate,
- and aligned with your device’s risk profile.
For low and medium-risk devices, this very seldom requires a clinical investigation and can in most cases be part of the Post-Market Clinical Follow-Up (PMCF).
Grounded in Research, Not Assumptions
Our approach is rooted in scientific inquiry. We take part in the ECliPSE project, which focuses on one of the central challenges in medical device evidence generation: where exactly the line lies between non-clinical demonstration and the need for clinical data.
This work directly informs our methodology. It means our evidence strategies are not based on habit, preference, or “what the Notified Body might like,” but on defensible reasoning supported by clinical science, test methodology, and risk theory. Notified Bodies consistently accept this approach, not because it caters to individual reviewers, but because the underlying arguments are structured, transparent, and firmly grounded in evidence.
Why Escentia
Scientific and Transparent
We work with precision, clarity, and humility. No jargon, no unnecessary claims – just solid, defensible reasoning grounded in evidence.
Reliable and High-Quality
You receive premium-quality work delivered with the speed and structure your timelines demand. Accuracy and consistency are non-negotiable.
A Worthwhile Investment
A strong evidence strategy prevents unnecessary clinical investigations and reduces regulatory risk, often saving significant time and cost downstream.
Clear About Our Limits & Supported by Experts
We focus on what we do exceptionally well. When a project requires specialised clinical operations, advanced testing, or niche expertise, we draw on a trusted network of partners to ensure you get the right experts at the right moment.
Tailored to Your Device
There is no universal template. Every device has its own evidence story. We help you articulate it clearly, coherently, and in a way that stands up to scrutiny.
Contact us
Get in contact to find out how we can help your team.
FAQ
For most low- and medium-risk devices, particularly those that are standard of care, it is often possible to demonstrate safety and performance without a clinical investigation if the evidence strategy is designed intentionally from the start.
A clinical investigation is only required when a meaningful clinical question cannot be answered through non-clinical testing, risk analysis, usability data, or the scientific literature.
Our role is to help you determine, with defensible reasoning, whether such a question exists.
Often they can, when they are designed around the device’s interaction with the human body.
Clinical data is only necessary when a question about that interaction cannot be answered in a controlled, non-clinical setting. The key is understanding the physiological, biomechanical, and user-device mechanisms well enough to design tests that meaningfully represent real-world use.
Scientific literature provides the foundation: what is already known about similar technologies, anatomical constraints, failure modes, and clinical workflow. Non-clinical testing then builds on this by reproducing the relevant aspects of human physiology or behaviour through bench tests, models, simulations, and human factors engineering.
When these elements are grounded in scientific evidence and not assumptions or habit, they can answer many of the questions that would otherwise default to clinical data.
By designing the evidence strategy early, deliberately, and around the core clinical questions of the device.
Avoidance is not about arguing with the Notified Body, it’s about being able to show, with scientific clarity, that any residual uncertainties have already been resolved through appropriate non-clinical methods.
When clinical investigations are avoided successfully, it is usually because the manufacturer has:
- A clear clinical concept for the device
- A risk-driven justification for their evidence choices
- Non-clinical data aligned with clinical function
A traceable link from claims / risks → requirements → V&V → clinical evaluation
This is where we focus our work. scientific evidence and not assumptions or habit, they can answer many of the questions that would otherwise default to clinical data.
NB reviewers also work under their own constraints. When in doubt, they will naturally err on the side of asking for more clinical data. That means the evidence must be presented in a way that is easy to follow, coherent, and directly linked to the device’s risks, claims, and clinical questions.
A strengthened evidence strategy often resolves these concerns without generating new clinical data.
We do not optimise for “what the Notified Body likes”; we optimise for what is scientifically justified. NBs consistently accept this when the reasoning is sound.
This line is narrower and more interesting than most people think.
The ECliPSE project, which we contribute to, is actively investigating this question: when can a clinical claim be demonstrated using non-clinical methods, and when does it truly require human data?
While the research is still evolving, we already apply sound, scientifically grounded methods to individual devices. In practice, the line depends on the nature of the clinical question, the residual risks that remain after engineering controls, and the level of abstraction at which performance is being evaluated: physiological, biomechanical, behavioural, or purely technical.
When that line is understood clearly, the evidence strategy becomes far more predictable — and often far less reliant on clinical investigations.
Not automatically, but this is a very common misconception.
And if the question is phrased this way to a Notified Body, the answer will almost always be yes.
Not because it is always required, but because the question is too broad and creates uncertainty and in uncertainty, NB reviewers will default to asking for clinical data.
The real question is: can the clinical claim be demonstrated through scientifically sound non-clinical methods?
For many low- and medium-risk devices, the answer is often yes.
For example, if a device claims an effect that is directly linked to a measurable, technical mechanism, such as reduced leakage, faster workflow, or more consistent delivery, this can often be demonstrated through well-designed bench testing, modelling, usability studies, and structured scientific literature rather than human data.
Clinical data becomes necessary only when the claim depends on complex human physiology or behaviour that cannot be reliably reproduced outside a clinical setting.
In short: a clinical claim does not automatically mean clinical investigation.
It means a clear clinical question, and an evidence strategy designed to answer it in the most efficient, scientifically defensible way.
Not necessarily.
Needing clinical data for a claim is not the same as needing a pre-market clinical investigation.
MDR 61(10) allows certain devices, particularly low- and medium-risk, standard-of-care technologies, to be placed on the market based on non-clinical data only.
If a marketing claim requires clinical data, the device can always be brought to market without this claim, which then can be supported following a clear PMCF strategy.
This is a legitimate and widely accepted approach: the device is marketed with transparent, defensible claims, and the missing clinical evidence is generated through PMCF rather than a pre-market study.
In short: a marketing claim that needs clinical data does not automatically block you from following MDR 61(10).
It simply requires a coherent evidence strategy: one that demonstrates safety and performance at launch, and uses a targeted PMCF programme to strengthen or extend claims responsibly.
Data from an equivalent device can still be used for initial CE marking, but its practical value under the MDR has become very limited.
The MDR sets strict and detailed criteria for demonstrating equivalence and as a result, true equivalence is now the exception, not the rule.
For low- and medium-risk devices, equivalence data also tends to cover only part of the picture:
- not all patient populations,
- not all indications,
- not all risk scenarios, and
- not the specific performance characteristics your device needs to demonstrate.
This leaves significant evidence gaps that manufacturers must address through extensive PMCF. In practice, this means an equivalence-based strategy may get you to market, but only at the cost of a substantial and long-term post-market clinical data burden.
For most devices, this approach is not advisable. A tailored evidence strategy built on your own non-clinical testing, clinical reasoning, and targeted PMCF tends to be more predictable, more defensible, and ultimately far more efficient under the MDR.