Regulation is Pushing European Medtechs to Streamline Clinical Trial Operations

The Growing Demands on European Medtech Clinical Trials

As the medtech industry evolves, companies are facing resource limitations, greater clinical evidence demands, site collaboration challenges, and the burden of manual processes. This leaves many teams juggling trials across different regions, sites, and systems, while trying to consolidate data and documentation for timely submissions. 

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). In response, many medtech organisations are focusing on streamlining their clinical trial operations and building a more connected digital foundation for clinical development. 

Managing Clinical Trial Data Under New EU Regulations

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 diversification is a direct response to new regulations requiring more robust clinical evidence across the product lifecycle, but it also introduces the risk of fragmented information and data silos.

Fragmentation makes it difficult to maintain continuous data review and cleaning for active oversight. Manual data reconciliation across multiple sources often leads to errors and missing data, and failing to spot these early can compromise compliance and increase the burden on clinical teams. Heavy administrative workloads in turn delay trial decisions and critical study milestones, like database lock and final submissions.

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. A structured data approach enables the active oversight needed to quickly resolve data issues and monitor trends, ensuring regulatory compliance and driving innovation.

The Digital Opportunity for European Medtech

With a global uptick in the use of connected digital systems to support clinical trials, European medtechs still have further opportunities for digitalisation. Currently, 34% of European companies have implemented eTMF, CTMS, and EDC as part of their core clinical systems, compared to 48% in North America. 

This trend 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 ROI of Clinical Trial Technology

Nearly three-quarters (74%) of medtech companies in Europe use 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 the greatest obstacle to transformation is the challenge of adequately demonstrating clear ROI  from new technology. 

Organisations are generally comfortable with operational KPIs that focus on process efficiency,  but tracking transformational metrics that link technology to business impact has proven harder. By showing how specific technology-driven improvements, like faster study set-up times, quicker data review and cleaning, and reduced time to database lock, shorten trial timelines, clinical teams can clearly link their technology investments to strategic outcomes like earlier market access. 

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 Clinical Research Site Partnerships

Clinical research sites are the backbone of medtech trials, but sponsors often struggle to  secure top-tier partners. Exhausted by heavy workloads, the most competitive sites are drawing a hard line and actively rejecting sponsors that rely on disconnected systems and manual processes.  

To understand why, we can look at the administrative burden on site staff at every stage of a study. It begins during trial set-up with repetitive manual document exchanges. Once the study is active, staff juggle multiple technologies and logins to manage trial logistics. During patient visits, non-intuitive platforms and constant query exchanges inevitably lead staff to delay clinical data entry. 

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 ongoing partnerships with specialised sites across multiple product generations, easing the 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 Digital Foundation for Clinical Trials

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.

References

• EU Medical Devices Regulation (MDR): https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng
• EU In Vitro Diagnostic Medical Devices Regulation (IVDR): https://eur-lex.europa.eu/eli/reg/2017/746/oj/eng
• 2025 Veeva MedTech Clinical Benchmark Report: https://dm-live-medtech.agcdn.veeva.com/resources/2025-clinical-benchmark/

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.