When it comes to digital health, the conversation often starts and stops at regulation. How do we get CE marking? What does UK MDR mean for us? These are important questions, but if your regulatory strategy focuses only on ticking compliance boxes, you’re already at a disadvantage.
The reality is that a regulatory strategy should be about more than approval, it should be about commercial success. That means finding the most efficient path through complex frameworks, while designing a product that genuinely solves a clinical problem and integrates seamlessly into healthcare systems.
This was the focus of our recent webinar, Regulatory Strategy Essentials for Digital Health. Here are the key takeaways that stood out.
1. Regulatory Strategy Is Not an Isolated Project
Demonstrating conformity with medical device regulations is hard work. However, if you treat it as an isolated project, you risk ending up with a compliant device that nobody actually uses.
A strong strategy starts by asking:
- What clinical problem are we solving?
- How does this device fit into existing workflows?
- What route to market gives us the best balance of speed, cost, and long-term coverage?
Get those answers right, and the regulatory process becomes a tool to achieve commercial goals, not a barrier to them.
2. Understand the Clinical Problem First
In digital health, it’s easy to get carried away with technical brilliance, but unless your device addresses a defined clinical need, it risks gathering dust.
This involves two critical early-stage assessments:
- Burden of disease analysis: What’s the prevalence, diagnosis pathway, and treatment landscape today?
- Unmet needs analysis: Where are the gaps in current practice that your device can fill?
These insights not only guide device design but also ensure your product integrates into healthcare systems (e.g. electronic health records, care pathways) and avoids barriers to adoption later.
3. Defining Intended Purpose Early
Your intended purpose statement, a clear one-to-two-sentence description of what your device does, shapes your entire regulatory journey:
- It determines the clinical and technical evidence you must generate to support suitability for your intended purpose.
- It drives your state-of-the-art (SOTA) review, setting benchmarks for safety and performance.
- It defines device classification, determining regulatory costs, timelines, and the need for Notified Body involvement.
Getting this right early allows you to balance regulatory approval with marketability:
- A broad intended purpose makes your product attractive to buyers, but makes achieving regulatory approval more challenging.
- A narrow intended purpose makes regulatory approval easier, but limits marketability.
Striking the right balance from the outset is one of the most important decisions you’ll make.
4. UK vs EU: Choosing Your Route to Market
For digital health software, classification is where the UK and EU diverge most dramatically.
- Under UK MDR (2002): many software devices remain Class I with no Approved Body required.
- Under EU MDR (2017/745): most software is at least Class IIa, requiring lengthy and costly Notified Body involvement.
Currently, the UK is considering indefinite acceptance of CE marking, with the MHRA running a further consultation on this proposal, later in 2025. In the meantime, manufacturers have flexibility in choosing their route to market:
- Go EU-first for broad coverage
- Go UK-first for faster, cheaper entry and early traction.
Two important caveats to keep in mind:
- The UK MDR is expected to undergo changes to classification rules in 2026, which may bring them closer to the EU position. Timelines and final details remain unclear.
- The MHRA has proposed introducing a new route to market using international reliance for certain devices, relying on the approvals or certificates issued by regulatory authorities in Australia, Canada, EU/EEA and USA.
The right approach depends on your resources, your investors, and how quickly you need to generate revenue, but it’s essential to plan with these regulatory shifts on the horizon.
5. Conducting a State of the Art (SOTA) Review
A SOTA review helps you understand the current landscape of clinical practice, technologies, and evidence relevant to your device. It ensures your digital health product is benchmarked against comparable solutions, informs the type of clinical and technical evidence you need, and supports both regulatory submissions and commercial positioning.
Conducting a SOTA review is more than a box-ticking exercise. It enables you to:
- Identify competitor devices and solutions addressing the same clinical problem
- Analyse the quality of clinical evidence supporting those products
- Determine gaps and opportunities where your device can demonstrate additional clinical benefit, usability, or cost savings.
- Guide your own clinical studies, both pre-market and post-market, so you generate relevant, meaningful evidence rather than over-relying on equivalence claims or technical performance studies.
6. Generating Clinical Evidence for Digital Health
Digital health products face unique challenges when it comes to clinical evidence. Unlike hardware devices, software makes equivalence harder to demonstrate. Relying solely on equivalence creates commercial limitations. After all, if your device is “the same” as a competitor’s, you’ll often end up competing on price rather than value.
- Under both UK and EU regulations, making a successful equivalence claim requires similarity in technical and clinical characteristics. For software as a medical device (SaMD) Manufacturers must have access to sufficient information on the equivalent device in order to demonstrate a similar software algorithm and technical specifications, which is often complex and restrictive.
There are alternative ways to generate evidence that both satisfy regulators and strengthen your commercial position, without costly prospective clinical trials:
- Retrospective analyses: Retrospective studies can be used to support conformity, depending on your device’s intended purpose and claims.
- PMCF data from other territories: For example, PMCF data collected in the UK, USA, or other markets can be leveraged to support conformity under EU MDR.
Importantly, the safety and performance outcomes observed in the SOTA review can be used as benchmarks for generating your own clinical evidence. These benchmarks help define the standards your device needs to meet to demonstrate suitability for its intended purpose.
By combining these approaches, your SOTA review and clinical evidence strategy can do more than tick regulatory boxes. It can differentiate your device, justify your claims, and support adoption in healthcare systems like the NHS.
7. Future-Proofing in an Iterative World
Software evolves constantly, but regulation assumes static products. To avoid being trapped by your own documentation:
- Keep intended purpose broad, and add specificity through indications.
- Define acceptance criteria for updates (e.g. model retraining thresholds)
- Structure files so Notified Bodies can review changes quickly.
Done well, this means your product can evolve without every update turning into a regulatory roadblock.
Conclusion: Digital Health Essentials
Digital health is one of the fastest-moving areas in healthcare, but success doesn’t come from speed alone. It comes from pairing regulatory rigour with commercial vision.
The essentials are clear:
- Focus on the clinical problem/need for your device first and develop your device accordingly
- Define your intended purpose carefully
- Choose your regulatory pathway strategically
- Generate evidence that matters to both regulators and the market
- Plan ahead so your product can keep evolving.
At Mantra Systems, we see regulatory strategy not as a hurdle, but as a growth tool—helping innovators bring safer, smarter, and more impactful digital health products to market.
Are you developing a digital health product and need support with regulatory strategy? Our team specialises in guiding innovators through UK and EU frameworks, balancing regulatory compliance with commercial success.
Contact us today to discuss how we can help you build a pathway to approval and adoption.
