Europe’s changing macroeconomic and regulatory environment is prompting the medtech industry to rethink clinical processes and technologies. New insights reveal focus on establishing a unified digital foundation as medtech companies look to optimise data strategy, strengthen site collaboration, and innovate with AI.
As the medtech industry evolves, companies are facing resource limitations, greater clinical evidence demands, site collaboration challenges, and the burden of manual processes. For medtechs in Europe, these hurdles are further compounded by changing regulations like the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), unique regional requirements, and conservative investment strategies that slow adoption of digital solutions.
In response, many medtech organisations are focusing on streamlining their clinical trial operations and building a more connected digital foundation for clinical development.
Optimising data collection in a new regulatory era
EU MDR and IVDR raised the bar for clinical evidence across medtech, establishing a new baseline for market access. With the EU AI Act, the European Health Data Space (EHDS), and other regulations, the pressure to generate more comprehensive and continuous evidence is intensifying, making data strategy a competitive differentiator.
According to a 2025 industry benchmark survey of over 100 clinical leaders1, companies are now pulling data from a wider range of sources than ever before, including traditional EDC systems (77%), direct instrument data (71%), real-world evidence (65%), imaging results (39%), and eCOA (26%). This push for more evidence has increased the risk of fragmented information and data silos, making it harder to generate clear insights and stay compliant.
New mandates emphasise the importance of an organisation’s data strategy. European medtechs are keenly focused on this challenge, with 58% planning to optimise data collection and cleaning efforts over the next year. Medtechs are moving to actively connect and harmonise data through investments in their processes and infrastructure.
By using unified platforms to aggregate, clean, and harmonise disparate sources into a single source of truth, organisations can integrate non-contextualised registry and real-world data with contextualised data from clinical trials. This approach creates a consistent view of the patient journey, which satisfies regulators and accelerates innovation.
European medtechs have an opportunity to close the digital gap
Despite an uptick in the use of connected digital systems to support clinical trials, European medtechs trail their U.S. counterparts. Specifically, 34% of European companies have implemented eTMF, CTMS, and EDC as part of their core clinical systems, compared to 48% in North America.
This gap also extends to other clinical trial processes. For instance, 26% of European companies use digital applications to streamline site payment processes, versus 37% in the U.S. Similarly, 29% of U.S. companies make use of digital tools for eCOA and 37% for study-specific training, while only 19% of European medtechs do the same for either area.
This absence of a connected ecosystem can lead to operational bottlenecks, heightened compliance risk, and fragmented data across the clinical trial lifecycle. New requirements for clinical evidence, transparency, and security from EU MDR and IVDR, the EU AI Act, and the EHDS reinforce the need to unify data and systems through a solid technology foundation.
Measuring the return on technology investment
Nearly three-quarters (74%) of medtech companies in Europe use key performance indicators (KPIs) to measure trial performance, but only 35% apply these metrics to quantify the value of their technology investments. At the same time, 35% report that their greatest obstacle to transformation is the challenge of adequately demonstrating a clear return on investment (ROI) from new technology.
Organisations are generally comfortable with operational KPIs—metrics focused on process efficiency, such as query resolution times or site activation speed. However, tracking transformational metrics that link technology to business impact has proven harder. Companies can support a business case by combining both operational and transformational metrics.
This is especially relevant as the medtech industry starts to use AI. Sixty-five percent of European medtech organisations are creating the right infrastructure, like standardising clinical data aggregation and cleaning workflows and harmonising clinical processes for task automation, to get ready for AI. As medtechs take on these projects, outlining clear and actionable KPIs is critical.
Navigating change for compliant study training
Sponsors navigate a patchwork of local and regional regulations when executing clinical trials across Europe, providing a challenge for companies when it comes to study and protocol training. Beyond this regulatory complexity, medtech trials also face stringent product and procedural training. When asked about which aspect of the training process is most prone to non-compliance, 32% of European medtech companies reported managing protocol and regulation changes, and 19% stated challenges with meeting local training requirements.
When a protocol changes, a specific country introduces new regulations, or a product has a design or software update, study teams must distribute and manage this dynamic information to ensure that training is up to date throughout the trial lifecycle. Disconnected training workflows can lead to delays in study timelines and lapses in compliance, risks that can multiply managing a high volume of sites across different geographies.
Centralised training tools that integrate with core digital clinical systems allow sponsors to deploy updates instantly across all sites, helping teams adapt swiftly to regulatory, product, and procedural changes. By unifying training management and clinical operations, companies can more easily manage change, fulfill role-based and product-specific training requirements, and automate filing training certificates for ongoing inspection readiness.
Trial costs top priorities for outsourcing
Contract research organisations (CROs) are essential partners to complement internal clinical capabilities of medtech companies. With tight industry budgets, cost is a key factor, as 42% of respondents point to trial costs as their top priority while outsourcing. In comparison, only 13% cite access to study data, but factoring cost alone while working with CROs can overlook the foundation needed for strategic collaboration and required oversight.
The traditional focus on pricing creates an operational blind spot, as outsourcing execution does not outsource accountability. For sponsors that juggle multiple CROs, study teams often encounter delayed reports and disconnected systems. To maintain the seamless data access required for comprehensive oversight, medtechs can establisha technology foundation to support collaboration with partners.
Current data highlights that European sponsors lag behind their U.S. counterparts in adopting unified eISF and eTMF systems to manage trial documents with partners. Instead, they are more likely to use manual methods like email and paper shipments, creating operational bottlenecks and elevating the risk of non-compliance with EU MDR and IVDR mandates on continuous clinical evidence and active sponsor oversight.
| Which methods does your organization use to exchange trial data and documents with study partners? | ||
| Method | Europe | United States |
| Unified eISF and eTMF | 42% | 63% |
| 68% | 55% | |
| File share or portal | 71% | 79% |
| Paper shipments | 23% | 9% |
| Fax | 3% | 1% |
Table 1. Regional comparison of methods to exchange trial data and documents
To counter this, data access will be a key pillar for the industry. Investing upfront in unified, sponsor-owned platforms ensures real-time visibility, eliminates the hidden downstream costs of manual oversight, and builds CRO partnerships that deliver both regulatory compliance and long-term efficiency.
Strengthening site partnerships for better trials
Clinical research sites often bear the brunt of managing complexity in global medtech trials. But top-tier sites are now drawing a hard line, and the most competitive sites are actively rejecting sponsors that rely on disconnected systems and manual processes. This reality is reflected in the data: sponsors report challenges with on-time data entry (52%), document exchange (45%), and perhaps consequently, the identification of study sites (48%). With nearly half of sponsors citing site identification as a top challenge, this finding reveals the impact of high-performing sites turning down inefficient collaborations.
A unified clinical platform with streamlined workflows can enable medtechs to compete in this landscape. In an industry reliant on repeat collaborations with specialized sites across multiple product generations, easing the site administrative burden strengthens these foundational relationships that power clinical research. By eliminating manual friction, sponsors can cement their status as a “sponsor of choice” and secure long-lasting site partnerships for faster, more efficient trials.
A unified foundation for future innovation
European medtechs stand at a strategic crossroads, facing new regulatory demands, a turbulent global market, and the promise of emerging AI technology. To navigate this landscape, building a unified technology foundation can help companies:
- Harmonise data with compliance and innovation in mind
- Build a connected digital ecosystem for holistic trial management
- Focus on key metrics to create a business case for future innovation
- Ensure training compliance with built-in change readiness
- Drive oversight and real-time data control when outsourcing to CROs
- Reduce the administrative burden on sites to develop stronger partnerships
By connecting data, documents, and workflows across the clinical lifecycle, medtechs can gain visibility and efficiency needed to make proactive decisions, accelerate study timelines, and ensure a continuous flow of high-quality data. And to prepare for AI implementation, clean, contextualised data and a unified technology foundation will be key.
By establishing a unified foundation, European medtechs can satisfy rigorous regulatory standards and create a future-proof structure needed to lead innovation for patients.
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