Why digital self-triage and MDR pave the way for healthcare in EU

Under the EU Medical Device Regulation (MDR 2017/745), software that supports clinical workflows, diagnostics, or decision-making is classified as a medical device and must be CE-marked in conformity with MDR to be legally placed on the market. Transitional provisions for legacy devices expire between 2027–2029, depending on classification.  Platform24’s products are CE-marked under MDR, meaning that they are reviewed by an external organization that identifies potential risks to ensure patient safety. Automated digital self triage can route patients to the appropriate care unit or level of care, help prioritize urgency, and streamline the patient journey.

Platform24 Digital Self Triage: What becomes possible with CE mark under MDR

Decision Support and Automation:

Platform24’s MDR‑certified (CE‑marked) self‑triage isn’t just an intake form, it is validated to support clinical decision‑making and safe automation.

The Platform24 triage system delivers trusted recommendations and can automate routing based on the information collected—driving major efficiency gains and strengthening patient safety. Using clinical assessment and locally defined operational rules, it directs patients to the right level of care. Routing isn’t about defaulting to the lowest level; it’s about matching each patient to the most appropriate care given their needs, urgency, and available resources.

Continuous Improvement

The products CE-marked under MDR are governed by a robust regulatory framework which means that updates, enhancements, and new features can be introduced continuously. Ongoing assessments ensure that safety and compliance are maintained over time.

Integration and Trust
The CE mark strengthens trust among regulators and healthcare providers, making it easier to integrate with national and regional systems. It demonstrates that the solution meets high standards for safety, performance, and reliability.

Data Security and Risk Management
Certified solutions are developed and maintained according to strict processes designed to minimize patient risk, protect sensitive data, and ensure full traceability throughout the system lifecycle.

Future-proofing
Investing in an MDR solution means you’re ready for tomorrow’s requirements and standards, not just today’s.

Limits Without MDR Certification

• No Clinical Decisions: The system cannot provide medical recommendations or automate care routing. It may only collect patient information, without drawing conclusions or making self triage decisions.
• Less Efficiency Gains: Since information can’t be interpreted or acted upon automatically, real efficiency gains are lost—the process remains manual and time-consuming, counteracting much of the value of digital transformation.
• No Updates or Improvements: For devices not CE-marked under MDR, only limited safety updates may be legally permitted during transition. Feature upgrades or new functions typically require MDR conformity. . Stagnation is the norm—new learnings and features can’t be rolled out as fast as in MDR-certified products.

How is Platform24 audited and how we maintain our certification

Every update to an MDR-certified digital self-triage solution must meet rigorous standards for quality control, clinical safety, and regulatory compliance. This is why Platform24 follows strict processes for documentation, testing, and validation—ensuring that each release protects both patients and care providers.

Platform24’s CE-marked devices undergo Notified Body audits at least yearly to verify conformity towards MDR regulationsThese audits cover a wide range of areas, including software lifecycle management, post-market surveillance, labelling, instructions for use, and more.

The bottom line:

The future of healthcare is digital—and the future of digital healthcare is regulated. Only CE-marked self-triage solutions in conformity with MDR  offer the safety, flexibility, and accountability the healthcare sector now demands.

To build long-term trust and future-proof operations, care providers and health systems need certified solutions that are built for tomorrow’s needs. Platform24 delivers this essential infrastructure, with tools designed to meet the highest standards today—and stand the test of time.