Medical Device Classification
Is the RestartiX platform a medical device? What does that mean for clinics and patients?
The Short Answer
The platform's clinical features — exercise prescription, treatment plan management, telerehabilitation with video guidance, patient progress tracking, and camera-based clinical measurement tools — are used for treatment, monitoring, and measurement of patients. Under European and US regulations, software with a medical intended purpose qualifies as a Software as a Medical Device (SaMD).
The product's features determine whether it's a medical device. Certification proves it was built to the required safety standard.
Who Decides
The platform operator doesn't decide. The regulatory authority does, based on the product's intended purpose.
| Region | Authority | Regulation |
|---|---|---|
| European Union | National competent authorities (e.g., ANMDMR in Romania) | EU Medical Device Regulation (MDR 2017/745) |
| United States | FDA | FDA Software as a Medical Device guidance |
The classification is triggered by how the product is described and marketed. A platform described as providing "telerehabilitation", "exercise prescription for recovery", or "range of motion measurement" is making medical claims — which means the software is a medical device.
Expected Classification
Two tiers of clinical features
The platform contains two levels of clinical functionality, each with different regulatory implications:
Tier 1 — Treatment assistance (likely Class I)
Features that help specialists deliver treatment, but where the specialist makes all clinical decisions:
| Feature | What It Does |
|---|---|
| Exercise Library | Video catalog with contraindications and instructions |
| Treatment Plans | Structured rehabilitation programs prescribed by specialists |
| Guided Sessions | Patients follow specialist-prescribed exercises with video guidance |
| Progress Tracking | Completion data, pain levels, and adherence visible to specialist |
In this tier, the software assists but doesn't decide. The specialist reviews the data and makes clinical judgments. This typically falls under Class I (lowest risk).
Tier 2 — Clinical measurement (likely Class IIa)
Features that provide objective measurements used for clinical decisions:
| Feature | What It Does |
|---|---|
| Virtual Goniometer | Measures joint angles (range of motion) in degrees using the device camera |
| Posture Analysis | Identifies posture deviations from neutral alignment |
| Movement Quality Assessment | Evaluates exercise form and technique using pose detection |
These tools are intended to replace physical clinical instruments (goniometers, posture grids). Specialists use these measurements to assess patient progress, adjust treatment plans, and make clinical decisions. Under EU MDR Rule 11, software that provides measurements used for diagnosis or treatment decisions is classified as Class IIa (moderate risk).
Why Class IIa matters
Class IIa requires more than Class I:
| Area | Class I | Class IIa |
|---|---|---|
| Certification process | Self-declaration (with some requirements) | Independent audit by a Notified Body |
| Clinical evidence | Documentation of intended purpose | Clinical evaluation — evidence that measurements are accurate and reliable |
| Quality management | Basic documentation | Full Quality Management System (ISO 13485) |
| Post-market surveillance | Basic | Active monitoring, periodic safety updates |
| Risk management | Basic risk assessment | Full ISO 14971 risk management file |
Clinical validation is the key addition: for the measurement tools, the platform will need to demonstrate that the virtual goniometer produces measurements within a clinically acceptable margin of error compared to a physical goniometer. This requires testing with real patients under controlled conditions.
Phase 2 implications
When the platform adds real-time patient feedback ("straighten your back", "bend deeper"), the software begins making autonomous assessments without a specialist in the loop. This could push classification further, depending on the nature of the feedback and whether it influences clinical outcomes.
Which Features Are Regulated
Not every feature in the platform is a medical device function. Only the features with a clinical purpose fall under medical device regulations.
Clinical features (regulated)
| Feature | Why It's Regulated | Risk Level |
|---|---|---|
| Exercise Library | Exercises include contraindications — showing the wrong exercise could cause harm | Lower |
| Treatment Plans | Prescribed rehabilitation programs with specific parameters | Lower |
| Guided Sessions | Patients follow exercises with video guidance based on their prescription | Lower |
| Progress Tracking | Data used by specialists to make clinical decisions about treatment | Lower |
| Virtual Goniometer | Provides range of motion measurements used for diagnosis and treatment | Higher |
| Posture Analysis | Provides clinical posture assessments | Higher |
| Movement Quality | Evaluates exercise technique and form | Higher |
| Video Consultations | Clinical assessments and decisions made during video calls | Lower |
Administrative features (not regulated)
Appointment scheduling, billing, forms, consent management, automations, PDF generation, webhooks, and organization management are administrative tools — they don't serve a clinical purpose and are not subject to medical device regulations.
What This Means for Clinics
Clinics using a certified medical device platform can:
- Demonstrate compliance to regulators and insurers
- Meet procurement requirements for hospitals and large healthcare organizations that require CE marking or FDA clearance
- Reduce liability — using a certified tool shows due diligence in the event of any clinical issue
- Offer remote measurement — objective clinical data from patients at home, without requiring an in-person visit for every measurement
What This Means for Patients
Certification means the software has been independently reviewed for safety:
- The exercises shown are the right exercises for the patient's condition
- Treatment parameters are correct and properly tracked
- Measurements are accurate — the virtual goniometer has been validated against physical instruments
- Clinical data is reliable and protected
Certification Path
| Phase | What Happens |
|---|---|
| During development | Build with documentation discipline — the platform already does this |
| Before first serious client | Engage a regulatory consultant for a formal gap analysis |
| Clinical validation | Test measurement tools against physical instruments on real patients |
| 6-12 months before certification | Prepare formal documentation, complete required testing, establish quality management system |
| Certification | Independent audit by a Notified Body (EU) or FDA review (US) |
Possible strategies
Strategy A — Certify in tiers. Launch with Tier 1 features (treatment assistance) under Class I, which has a lighter certification process. Add measurement tools after achieving Class IIa certification separately. This gets the product to market faster.
Strategy B — Certify everything at once. Target Class IIa from the start, covering both treatment assistance and measurement tools in a single certification process. More work upfront but avoids re-certification.
The right strategy depends on business priorities and timeline. A regulatory consultant can advise on the optimal path based on the planned feature rollout and target market.
Current Readiness
The platform was built with certification in mind from the start:
- Comprehensive documentation — every feature, architecture decision, and compliance requirement is documented
- Audit trail — tamper-proof, append-only logging of every data change, retained for 6 years
- Data isolation — database-level separation between clinics, verified independently of application code
- Encryption — data protected in transit and at rest, with additional application-level encryption for sensitive fields
- Clean architecture — clinical features are architecturally separated from administrative features, making the regulatory boundary clear
What's still needed
- Clinical validation of measurement tools (accuracy testing against physical instruments)
- Quality Management System (ISO 13485) for Class IIa
- Formal risk management file (ISO 14971)
- Regulatory consultant engagement for the certification process
Glossary
| Term | What It Means |
|---|---|
| SaMD | Software as a Medical Device — software that is itself a medical device |
| IEC 62304 | International standard for how medical device software should be developed |
| ISO 13485 | Quality management system standard for medical device organizations |
| ISO 14971 | Risk management standard for medical devices |
| EU MDR | European Union Medical Device Regulation |
| CE Marking | Certification mark showing the product meets EU health and safety standards |
| Notified Body | Independent organization that audits medical devices for EU certification |
| Class I | Lower risk — software that assists clinical decisions |
| Class IIa | Moderate risk — software that provides measurements for clinical decisions |
| Clinical validation | Testing that proves the software's measurements are accurate compared to established methods |
For developers
The full technical gap assessment, IEC 62304 requirements mapping, regulatory boundary analysis with code references, and detailed certification timeline are available in the Medical Device & IEC 62304 — Technical Assessment.