What are Smart Care Plans and how is it connected to MDR?

Smart Care plans are structured, personalized plans designed by Platform 24 to guide patient care over time—especially for those with chronic, complex, or rehabilitation needs. Platform24 offers various types of care plans tailored to the patient’s needs, such as plans for cancer treatment or maternity care, for example. Smart Care plans improve coordination, automate manual tasks, drive person-centered care, and support multi-professional collaboration. For care providers, these plans bring order, clarity and shared goals into patient journeys—potentially resulting in better clinical outcomes and greater patient empowerment.

The Promise—and Limitations—of Digital Care Plans

Traditional digital care plans are primarily static templates: the care provider must decide which goals, activities, or monitoring points to set, and is also responsible for interpreting all clinical results and alerts. While structured, this approach is limited in flexibility and scalability. It can become a burden for clinicians to continually review each piece of data, make adjustments, and track broader populations.

MDR: A Game Changer for Care Plans

The European Medical Device Regulation (MDR) sets standards for digital health products that affect clinical decision-making or patient safety. When a digital care plan platform like Platform24’s Smart Care Plans module is CE marked under the MDR, the possibilities expand significantly.

Why MDR and Smart Care Plans improve care for patients 

• Modifiable, patient-specific plans: CE-marking under MDR certification allows care plans to be more than static templates. The system can dynamically adapt plans to individual patient needs, conditions, and responses.
• Real-Time monitoring and alerts: CE-marking under MDR certification enables intelligent automation. The system can analyze patient-reported outcomes or clinical measurements in real time, issuing alerts for deviations or risks—helping clinicians focus where it’s needed most.
• Automated decision support: CE-marking under MDR certification allows the system to make certain clinical decisions, such as recommending actions or adapting the plan, within set and validated parameters—always under the clinician’s ultimate oversight.
• Continuous updates: With MDR, the care plan is not a static file but a living document—updated by both patient input and clinical data, with automated tracking and escalation if plans veer off course.

Without MDR: What’s Missing?

Without CE-marking under MDR certification, digital care plans are just documentation and messaging tools. The platform cannot automate clinical decisions or dynamically tailor care in response to real-world data. All clinical interpretation and adaptation falls on the care provider, meaning efficiency gains, scalability, and some safety features are lost.

Example: Blood Pressure Care Plan – With and Without CE marking under the MDR

**Without CE-marking under MDR Certification**

A patient with hypertension receives a care plan template asking them to report blood pressure weekly. The care provider receives every data point, sorts through results, and must manually identify any outliers or trends, then intervene.

**With CE-marking under MDR Certification**

The same patient’s inputs are monitored in real time by the system. If readings are outside personalized targets, the system issues alerts, provides next-step recommendations to the patient directly (such as retake measurement, answer a questionnaire or provide more information to the practitioner), and updates the clinical team only when escalation is needed.

Bottom Line: 

With CE marking under the MDR, care plan platforms like Platform24’s can move from static documentation to dynamic, patient-specific and safety-enhancing clinical tools. This means more efficient workflows for clinicians, more individualized care for patients, and increased capability for digital health to drive better outcomes at scale.