Not every product fits neatly into "medical device" or "not a medical device." Many innovations — particularly in digital health, wearables, and AI — sit on the borderline. The regulatory status of these products is ambiguous, and the wrong determination can cost your startup years of unnecessary compliance work or, worse, expose you to enforcement action for placing an unregulated medical device on the market.

Here is how to work through the borderline determination systematically.

Why Do Borderline Products Exist?

The MDR was designed primarily for traditional medical devices — instruments, implants, surgical tools, imaging equipment. The regulation's definitions work well for these products. But technology moves faster than legislation, and many modern innovations do not fit the categories the regulation anticipated.

Digital health products are the most common borderline cases. A mobile app that uses AI to analyze skin photos for suspicious moles — is that a medical device? A wearable that detects falls and automatically alerts emergency services — medical device or safety device? A chatbot that provides mental health support based on cognitive behavioral therapy principles — medical device, wellness tool, or something else entirely?

The answer depends on the specific claims, the specific functionality, and the specific interpretation of Article 2(1). And reasonable experts can disagree.

What Is the EU Framework for Borderline Decisions?

The European Commission maintains a Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices . This manual collects classification decisions and precedents to guide manufacturers, Notified Bodies, and competent authorities.

At the EU level, the MDCG can issue guidance on qualification and classification questions. Key guidance documents include:

  • MDCG 2019-11: Guidance on qualification and classification of software in Regulation (EU) 2017/745
  • MDCG 2021-24: Guidance on classification of medical devices

At the national level, each member state's competent authority can make borderline determinations for products marketed in their territory. In Germany, this is the BfArM. In Austria, BASG. In France, ANSM .

Article 4 of the MDR also gives the European Commission the power to determine, by means of implementing acts, whether a specific product falls within the definition of a medical device or an accessory .

How Do You Analyze a Borderline Product?

Work through this decision tree:

Step 1: Identify All Claims

Collect every statement your company makes or intends to make about the product. This includes: - Product label and packaging - Instructions for use - Marketing website - App store description - Sales materials - Published studies or white papers - Press releases - Investor materials (if public)

Look for any claim that references a specific medical condition, diagnostic function, therapeutic effect, or patient population. Even indirect references count — "validated for use by patients with Type 2 diabetes" puts a product in medical device territory even if the primary claim is wellness-focused.

Step 2: Apply the Article 2(1) Definition

For each claim, ask: does this claim establish an intended purpose that falls within Article 2(1)?

The medical purposes listed in Article 2(1) are: - Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease - Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or disability - Investigation, replacement, or modification of anatomy or a physiological/pathological process or state - Providing information by means of in vitro examination of human specimens

If any claim establishes one of these purposes, the product is a medical device under the MDR.

Step 3: Assess the Mechanism of Action

If the product has a medical purpose, confirm it does not achieve its principal intended action through pharmacological, immunological, or metabolic means. If it does, it is a medicinal product, not a medical device.

Step 4: Check Annex XVI

Even if the product has no medical purpose, check whether it falls into one of the Annex XVI product groups. If it does, it is regulated under the MDR once the relevant common specifications apply.

Step 5: Document Your Conclusion

Whether you conclude the product is a medical device or not, document the analysis. Include the claims assessed, the regulatory provisions applied, and the reasoning for your conclusion. This documentation is your defense if a competent authority later disagrees.

Common Borderline Scenarios for Startups

Health monitoring apps: An app that displays heart rate data from a wearable sensor is generally not a medical device — it is just presenting information. An app that analyzes heart rate data and provides a specific medical interpretation (e.g., "irregular rhythm detected — possible atrial fibrillation") is a medical device. The distinction is between data display and medical interpretation.

AI-powered image analysis: An app that enhances photos of skin lesions for better visibility is unlikely to be a medical device. An app that classifies skin lesions as benign or suspicious based on an algorithm is a medical device — it is performing diagnosis.

Mental health tools: A meditation app that guides breathing exercises for general relaxation is not a medical device. An app that delivers structured cognitive behavioral therapy for diagnosed depression is likely a medical device — it is providing treatment for a specific condition.

Posture correction devices: A wearable that vibrates when your posture deviates from ideal is borderline. If marketed for "general posture awareness and comfort," it may not be a medical device. If marketed for "prevention or treatment of musculoskeletal disorders," it is a medical device.

Fall detection systems: A device that detects falls and alerts contacts is borderline. The fall detection function itself may not be medical (it is a safety function). But if the device also monitors gait patterns to predict fall risk in patients with neurological conditions, the predictive medical function brings it into scope.

What If Different Member States Disagree?

This happens. The MDR is a regulation, so the legal text is identical across all member states. But the interpretation of borderline cases can differ between competent authorities. A product deemed a medical device by the German BfArM might not be classified the same way by the French ANSM.

In practice, if you plan to market across the EU, the most conservative interpretation tends to prevail. If any competent authority in a member state where you sell your product determines it is a medical device, you face enforcement in that market regardless of what other authorities have said.

The safest approach for products that could go either way: 1. Get a formal determination from the competent authority in your primary market 2. Document the determination 3. If you plan to sell in other member states, check whether those authorities have taken a different position on similar products 4. If there is a conflict, elevate the question to the MDCG level or treat the product as a medical device across all markets

The Strategic Dimension of Borderline Products

For startups, the borderline determination is not just regulatory — it is strategic. Here is the framework:

If the medical claims are essential to your value proposition — your product's core selling point is that it diagnoses, monitors, or treats a medical condition — then you need MDR compliance. The medical claims are your competitive advantage. Without them, you are just another wellness product. Accept the regulatory burden and build it into your business plan.

If the medical claims are optional — your product has strong non-medical value and the medical claims would be an enhancement — then you have a genuine strategic choice. You can launch as a non-medical product and add medical claims later, or you can pursue MDR compliance from the start. The beachhead approach (launching wellness, transitioning later) is a valid strategy in this scenario. See The Beachhead Strategy: Launching as Wellness First, Then Transitioning to Medical Device.

If you are genuinely unsure whether your intended claims make your product a medical device — get clarity before investing. The cost of a borderline analysis (consulting a regulatory expert, seeking a competent authority opinion) is trivial compared to the cost of discovering you chose the wrong path after months of development.

At the end of the day, the borderline determination comes down to what you intend your product to do for the user. That intention, expressed through your claims, determines your regulatory path. Make the decision deliberately, not by accident.

Next: The Beachhead Strategy: Launching as Wellness First, Then Transitioning to Medical Device.