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, and patient progress tracking — are used for treatment and monitoring of patients. Under European 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.
Following a formal regulatory consultation (March 2026), the classification picture is now clear — and more nuanced than initially expected.
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 "adherence monitoring" is making medical claims — which means the software is a medical device.
Regulatory Classification
What the regulation says
MDR Rule 11 (Annex VIII) is the primary classification rule for medical device software:
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as Class IIa.
The MDCG 2019-11 Rev.1 guidance clarifies that this wording describes, in very general terms, the characteristic "mode of action" of all medical device software. Therefore, Rule 11 is generally applicable to all medical device software (except software without a medical purpose).
What this means for RestartiX
A regulatory consultant analyzed the platform's features against MDR Rule 11 and concluded that the following functions each independently trigger Class IIa classification:
| Function | Why It Triggers Class IIa |
|---|---|
| Treatment plan management | Software is part of the therapeutic process — supports medical decisions |
| Exercise library with contraindications | Medical content used in treatment, not general educational content |
| Progress tracking | Monitoring therapy implementation — even "light" behavioral monitoring counts |
| Adherence tracking | Adherence is a medical element — tracking it is therapy monitoring |
| Computer vision for exercise verification | A form of therapeutic behavior analysis — still monitoring |
| Guided rehabilitation sessions | Patient follows a medically prescribed program through the software |
Key insight: Even without measurement tools (goniometer, posture analysis), the core treatment and monitoring features already place the platform in Class IIa. The previous assumption that "treatment assistance = Class I, measurements = Class IIa" was incorrect.
The Class I alternative
There is one classification rule that allows Class I: Rule 13 ("all other active devices are Class I").
To use Rule 13, the platform's intended purpose must not declare that:
- Information managed by the platform is used for diagnostic or therapeutic decisions
- The platform monitors patient progress
- The platform supports therapeutic plan implementation
Several European competitors have successfully registered as Class I using this approach:
| Product | Country | Approach |
|---|---|---|
| Herodikos | Germany | Class I via Rule 13. User manual explicitly states: "not intended for diagnosis or monitoring" — though other marketing materials contradict this |
| eCovery | Germany | Class I (MDR). Positioned as exercise/digital guidance app |
| Bauerfeind Therapy App | Germany | Class I (MDR). Orthopedic rehabilitation exercises |
| SilverFit (Newton, Mile, Flow, etc.) | Netherlands | Class I via Rule 13. Public Declaration of Conformity available. Described as "motivational visualizations for exercises" — avoids therapeutic language |
| HoloMoves | Netherlands | Class I (MDR). Rehabilitation including neurorehabilitation |
Important caveat from the regulatory consultant: This approach is "not exactly proper" — it is an unorthodox way to avoid higher classification. EUDAMED registration does not verify the accuracy of declarations. Problems can arise later from competitors who properly certify their products, or from market surveillance authorities.
As of March 2026, no similar telerehabilitation software is registered as Class IIa in EUDAMED (though 1,515 Class IIa software products exist with other intended purposes).
Two Strategic Paths
Strategy A — Class I via Rule 13 (pragmatic)
Register as Class I by carefully framing the intended purpose to avoid triggering Rule 11. This is what competitors do.
Pros:
- Faster time to market
- Lower certification cost and complexity
- Self-declaration (no Notified Body audit)
- Proven path — multiple EU competitors operate this way
Cons:
- Requires careful wording — marketing, documentation, and user manuals must not claim therapeutic monitoring or clinical decision support
- Regulatory risk if authorities or competitors challenge the classification
- Creates tension between what the platform actually does and what is officially declared
Registration process:
- Register in EUDAMED (obtain manufacturer SRN number)
- Obtain Basic UDI-DI and UDI-DI codes from GS1
- Register with ANMDMR (Romanian national database)
Required documents: Declaration of Conformity, label, Instructions for Use (IFU)
Strategy B — Class IIa via Rule 11 (proper)
Pursue the classification that correctly reflects the platform's intended purpose.
Pros:
- Fully compliant — no regulatory risk
- Stronger position with large clinic networks, insurers, and institutional rehabilitation organizations
- No contradiction between product capabilities and regulatory declarations
- Competitive advantage as the market matures
Cons:
- Requires independent Notified Body audit
- Full Quality Management System (ISO 13485)
- Clinical validation for measurement tools
- Full ISO 14971 risk management file
- Significantly more time and cost
Recommended approach
Start with Strategy A (Class I) to enter the market, then pursue Strategy B (Class IIa) as the business grows. This is the path competitors have taken. The platform's documentation discipline and technical foundations make a future transition to Class IIa significantly easier than starting from scratch.
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 | MDR Impact |
|---|---|---|
| Exercise Library | Exercises include contraindications — showing the wrong exercise could cause harm | Triggers Rule 11 if declared as therapeutic content |
| Treatment Plans | Prescribed rehabilitation programs with specific parameters | Part of therapeutic process |
| Guided Sessions | Patients follow exercises with video guidance based on their prescription | Therapeutic implementation |
| Progress Tracking | Data used by specialists to make clinical decisions about treatment | Therapy monitoring |
| Adherence Tracking | Monitoring whether patients follow prescribed treatment | Therapy monitoring |
| Computer Vision | Verifying exercise execution via camera | Therapeutic behavior analysis |
| Virtual Goniometer | Measures joint angles (range of motion) in degrees | Clinical measurement — strongest Class IIa trigger |
| Posture Analysis | Identifies posture deviations from neutral alignment | Clinical measurement |
| Movement Quality Assessment | Evaluates exercise form and technique | Clinical measurement |
| Video Consultations | Clinical assessments and decisions made during video calls | Clinical decision-making |
Administrative features (not regulated)
Appointment scheduling, service plans, 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.
Registration Process and Costs
Regulatory registration fees
| Step | Authority | Cost |
|---|---|---|
| EUDAMED validation | ANMDMR | 276 RON |
| National database registration | ANMDMR | 1,638 RON |
| GS1 membership (one-time) | GS1 | 120 EUR |
| GS1 annual license | GS1 | 120 EUR/year |
Additional requirements
| Requirement | When Needed | Notes |
|---|---|---|
| Product dossier (risk analysis, essential requirements, post-market surveillance plan) | Not mandatory at registration, but can be requested by ANMDMR evaluator or during market surveillance | Strongly recommended to prepare proactively |
| Quality Management System (QMS) | Required by MDR Art. 10(9) | Two options: own QMS (non-certified) or ISO 13485 certified QMS. Certified QMS may be required by CNAS or institutional clients |
What This Means for Clinics
Clinics using a registered/certified medical device platform can:
- Demonstrate compliance to regulators and insurers
- Meet procurement requirements for large clinic networks and institutional clients that require CE marking
- Reduce liability — using a registered tool shows due diligence in the event of any clinical issue
- Offer remote monitoring — structured tracking of patient progress and adherence at home
What This Means for Patients
Registration/certification means the software meets safety standards:
- The exercises shown are appropriate for the patient's condition
- Treatment parameters are correct and properly tracked
- Clinical data is reliable and protected
- The manufacturer has a quality management process in place
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
For Class I registration:
- EUDAMED registration and SRN number
- UDI codes from GS1
- Declaration of Conformity
- Instructions for Use (IFU) and product label
- ANMDMR national registration
- Product dossier (recommended)
- Quality Management System (at minimum non-certified)
For future Class IIa certification:
- Independent Notified Body audit
- Certified Quality Management System (ISO 13485)
- Clinical validation of measurement tools (accuracy testing against physical instruments)
- Full risk management file (ISO 14971)
- Active post-market surveillance program
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 (2017/745) |
| CE Marking | Certification mark showing the product meets EU health and safety standards |
| ANMDMR | Romanian National Agency for Medicines and Medical Devices |
| EUDAMED | European Database on Medical Devices — central EU registration system |
| Notified Body | Independent organization that audits medical devices for EU certification |
| UDI | Unique Device Identification — standardized system for identifying medical devices |
| SRN | Single Registration Number — unique manufacturer identifier in EUDAMED |
| GS1 | International organization that issues UDI codes for medical devices |
| Rule 11 | MDR classification rule for software providing information for diagnostic/therapeutic decisions (Class IIa+) |
| Rule 13 | MDR classification rule for "all other active devices" (Class I) |
| Class I | Lower risk — self-declaration, lighter documentation requirements |
| Class IIa | Moderate risk — requires Notified Body audit and full QMS |
| CNAS | Romanian National Health Insurance House |
| 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.