As the medtech industry evolves, companies are facing resource limitations, the burden of manual processes, greater clinical evidence demands, and site collaboration challenges. 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 more 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 the 2025 Veeva MedTech Clinical Benchmark Report, 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 organization’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 contextualized 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 North American counterparts. Specifically, only 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, only 26% of European companies use digital applications to streamline site payment processes, versus 37% in North America. And just 19% of European medtechs make use of digital tools for eCOA and study-specific training, compared to 29% and 37% respectively in North America.
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.
Strengthening site partnerships for better trials
Managing complexity often comes at the expense of clinical research sites in global medtech trials. Disconnected systems and non-standard processes create operational friction, requiring sites to manage inconsistent training, duplicative data entry, and confusing document requests. This administrative burden slows down trials and strains sponsor-site relationships.
Two of the top challenges for European medtechs working with sites reflect this: on-time data entry and quality (52%) and data and document exchange (45%). These medtechs also reported identification of study sites (48%) and monitoring and compliance (45%) as areas for improvement, suggesting a gap in the processes and systems put in place by sponsors for site collaboration.
Simplifying the experience for sites can make collaboration more seamless. By providing a unified clinical platform with streamlined workflows, sponsors can reduce the administrative load on sites. In an industry where top-performing research sites can choose their studies, reducing friction is crucial to become a sponsor of choice and attract the best partners 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
- 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.
About the author
Stéphanie Flipo guides the strategic direction of Veeva MedTech’s clinical business in Europe. Throughout her nearly 20-year career with CROs and medtech organisations, she has developed deep expertise in the end-to-end clinical development process, collaborating with cross-functional teams to maximise the use of clinical evidence and accelerate patient access to treatments.
