Key Takeaways:
- EU HealthTech is shifting from US-first to regulatory-by-design & EU-first
- Regulation now drives strategy, timelines, and market access
- Intended use is the key early decision for a successful roadmap
- MDR/IVDR/AI Act require early, integrated compliance planning
- Clinical validation must prove real-world workflow impact
- Early collaboration with regulators, clinicians, and patients is critical
How is the European HealthTech innovation landscape evolving today around regulation, clinical validation, and time-to-market?
Raquel: Despite harmonization across EU member states, the complexity of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR) has led many HealthTech companies to adopt a “US FDA first” strategy. In response, the European Commission is encouraging an “EU-first” approach, promoting European-made technologies through incentives and funding for innovative solutions that create value within the EU and strengthen high-quality human resources.
The ecosystem is also maturing. To succeed, companies must integrate regulatory compliance early, generate robust clinical and cost-effectiveness evidence, and define a clear reimbursement strategy. HealthTech companies now navigate a complex regulatory framework including MDR, IVDR, Health Technology Assessment Regulation (HTAR), General Data Protection Regulation (GDPR), the AI Act for AI-enabled devices, and the emerging European Health Data Space. Early regulatory support is therefore essential to build credibility with investors.
Clinically, the sector is moving toward evidence-based solutions that integrate into workflows, focusing increasingly on continuous monitoring and prevention. Successful validation requires well-designed studies that generate robust, clinically relevant data while ensuring quality.
Regarding time-to-market, regulatory complexity has increased timelines, but startups can optimize development by adopting a regulatory-by-design approach and leveraging structured dialogues and other mechanisms provided by the European Commission and notified bodies.
Where do early-stage and scaling HealthTech companies most often misjudge the regulatory and clinical path for SaMD, IVDs, or AI-enabled medical devices?
Raquel: Early-stage and scaling HealthTech companies often underestimate the importance of regulatory science and of defining a regulatory and clinical evaluation strategy early. Many address these aspects too late, when changes to the product become costly.
Common mistakes include misclassifying the product within the regulatory framework and underestimating the effort required to define product requirements and design preclinical and clinical studies to generate the evidence supporting intended use. If evidence is insufficient, the notified body may not grant the CE mark, forcing additional data collection.
Another frequent misjudgment is timelines for clinical validation and certification. Startups sometimes pitch to investors six-to-nine-month plans, but realistically these processes may take two to four years. It is important to note that MDR and IVDR apply across all EU member states, a CE mark is recognized throughout the EU, giving companies broad market access, even though reimbursement must still be negotiated at the national or regional level. Despite longer timelines, a common EU regulatory framework is a clear advantage for entering the EU market.
What gap do you see between startups, healthcare institutions, and regulators that still prevents strong products from reaching the market?
Raquel: One of the biggest gaps is coordination between startups, healthcare institutions, and regulators. Traditionally, startups develop a product, test it in a healthcare institution, and only then seek regulatory approval. Today, companies succeed more often when they engage early with regulatory science experts, regulators, and notified bodies. At the same time, they should co-design the product and clinical validation process with healthcare professionals and involve patients through advocacy groups to ensure the solution meets real needs.
This collaborative approach allows startups to integrate regulatory and clinical requirements from the start, perform final clinical validation on a well-prepared prototype, and then submit for CE marking. Overall, this represents a shift from a linear, traditional process to a more integrated, efficient approach, increasing the chances of bringing strong products to market.
How do you support HealthTech companies across regulatory strategy, clinical validation, and interaction with EU authorities?
Raquel: Understanding and implementing regulatory science can be complex and time-consuming, particularly because it requires interaction with regulators and notified bodies. At CoLAB TRIALS, we support startups and SMEs by helping them navigate and streamline these processes.
We assist HealthTech companies in defining the device risk classification, developing the regulatory strategy, and preparing the clinical evaluation plan. We also support the design of preclinical and clinical studies, identifying the tests required to generate the technical, scientific, and clinical evidence needed for certification. In addition, we help prepare the technical and clinical documentation required for device certification under EU regulations, support the selection of the notified body, and facilitate interactions throughout the process from structured dialogues to certification procedures.
Any success stories of startups you’ve helped to market?
Raquel: CoLAB TRIALS has contributed to the development of 38 innovative health products - including medical devices, medicinal products and new methodologies – by providing support across 3 core areas: pre-clinical study design, clinical study design, scientific and regulatory strategy. More than 18 companies have benefited from our expertise to strengthen their product development and to streamline their regulatory pathways.
Through our associates in Portugal and a broader EU network of partners, including clinical trial units, we can facilitate clinical validation of innovative health products by guiding clinical study design and coordinating partners for the submission, conduct and monitoring of the cross-border clinical studies. In this way, CoLAB TRIALS assists startups through an integrated and full lifecycle from early validation till certification.
When a startup begins working with you, what does the collaboration typically look like from first engagement through clinical validation or regulatory submission?
Raquel: The collaboration usually begins with an introductory meeting to understand the product, its development stage, and intended use. We then define the objectives and specific services needed, which are tailored to the product. Each service is structured as a project with defined tasks, carried out in close collaboration between the startup team and CoLAB TRIALS. Throughout the process, we maintain regular meetings and ongoing communication to review progress and documentation, ensuring the project aligns with regulatory and clinical requirements. We also agree on a timeline and budget, formalized through a service agreement and non-disclosure agreement. From there, we work closely with the startup to develop studies and prepare all documentation required for CE marking and regulatory submission.
When a startup has a strong product but limited regulatory clarity, which early decisions most affect approval risk, timelines, and cost the most?
Raquel: The most important early decision is defining the intended use of the device. This determines the regulatory framework, risk classification, roadmap, general safety and performance requirements, clinical evaluation strategy, and type of conformity assessment. For example, Class I devices carry the lowest risk under MDR, where the manufacturer can self-declare conformity and clinical trials are not mandatory. In contrast, Class III devices carry the highest risk, requiring notified body assessment and clinical trials, which significantly impacts timelines and costs. Engaging early with regulatory experts helps reduce uncertainty, minimize risk, and avoid costly redesigns or repeating validation studies later.
In practice, how do regulatory and clinical pathways differ when working with medicinal products versus SaMD or IVDs?
Raquel: In practice, medicines and medical devices are evaluated quite differently, both from a regulatory and clinical perspective.
Medicinal products are regulated by the European Medicines Agency (EMA) through a centralized process. Clinical trials must comply with the Clinical Trial Regulation, requiring approval from competent authorities and ethics committees via the Clinical Trials Information System, which centralizes submissions across all EU member states. Medical devices including regular devices, SaMD, and IVDs are certified by notified bodies under MDR or IVDR, and the CE mark is valid across all EU countries. While EUDAMED exists to centralize device information, its module for clinical investigations and performance studies is not yet functional. As a result, clinical studies in multiple countries still require individual submissions to each authority.
Generally, development to approval takes longer for medicines, while device development is faster and iterative, especially for SaMD. However, significant changes such as software updates may require recertification. Clinical validation also differs: medicines follow Phase 1-4 trials to assess safety and efficacy, often starting with healthy volunteers. Devices use pilot, pivotal, and post-market studies to evaluate safety and performance, usually without healthy volunteers for ethical reasons. Study design, the use of placebo or blinding, and participant numbers also differ, with smaller sample size for devices.
For founders building AI-driven medical products, what regulatory or clinical decision should be made earlier than it usually is?
Raquel: For AI-driven medical devices, the most critical early decision is still defining the intended use. Beyond that, founders need to design the technical architecture with regulatory compliance in mind not only under MDR or IVDR, but also the AI Act, including principles like Trustworthy and Explainable AI, transparency and human-in-the-loop.
Data governance is another early consideration, since compliance with GDPR must be integrated alongside medical device requirements. Importantly, the risk classification must align across all applicable frameworks, as the MDR and AI Act may differ. Ensuring compliance with all relevant regulations from the start reduces risk, avoids costly redesigns, and helps guide both development and clinical validation.
Also, HealthTech companies should develop robust plans for continuous monitoring and controlled updates (with recorded changes) to address safety concerns including AI model drift, hallucinations, cybersecurity, as well as automation bias (over-reliance by clinicians, neglected alerts or increased false alerts).
Looking ahead, what changes in regulation, collaboration, or funding would most accelerate HealthTech innovation in Europe?
Raquel: Acceleration of HealthTech innovations can be achieved by a faster regulatory roadmap and more predictable timelines and costs (especially certification process by Notified Body and re-certification burden, digitalisation), digital transformation of certification process and all modules of EUDAMED becoming live, aligning overlapping frameworks (e.g. MDR, AI Act, EHDS), and scaling regulatory sandboxes. At the same time, stronger cross-border collaboration between HealthTech innovators, regulatory science experts, clinicians, patient advocacy groups and regulators would lower evidence costs and speed adoption. Finally, targeted funding to help startups cover clinical evidence collection, compliance and scale would ensure that innovations not only reach the market faster but are deployed in healthcare systems.
R2GConnect: Thank you very much for the insights, Raquel.
To support HealthTech innovators, CoLAB TRIALS is offering a set of exclusive deals designed to accelerate regulatory and clinical pathways to market in Europe. Explore
- Regulatory science for Medical Devices - learn more here
- IVD Medical Device Regulatory Support and Clinical Validation - learn more here
- SaMD Regulatory Support and Clinical Validation - learn more here
- Medicinal Products Regulatory Strategy and Pre-Clinical & Clinical Study Design - learn more here