Introduction
At Patient Guard, we help simplify this process with our user-friendly Medical Device software compliance tools, designed to guide you through product determination and classification. These tools provide clarity, save time, and reduce the risk of regulatory errors.
Why Use Medical Device Regulatory Software?
Determining whether your product qualifies as a medical device under EU MDR — and if so, what classification it falls under — is one of the first and most critical steps in your regulatory journey.
Getting it wrong can lead to:
- Costly delays
- Regulatory rejections
- Product recalls
- Increased compliance costs
With Patient Guard’s intuitive Medical Device software compliance tools, you can eliminate uncertainty, speed up your decision-making, and ensure your product is on the right regulatory path from the start.
🛠️ 1. Medical Device Determination Tool
Is your product a medical device under EU MDR 2017/745?
Our Medical Device Determination Tool helps you answer this vital question quickly and accurately. The tool takes you through a clear, step-by-step process, asking targeted questions about your product’s intended use, features, and functionality.
✅ Key Benefits:
- Quickly identifies whether your product is regulated under EU MDR
- Removes uncertainty from early-stage product development
- Prevents costly mistakes by ensuring correct classification from the start
📊 2. Medical Device Classification Tool
Once you know your product is a medical device, the next step is determining its risk classification. The EU MDR defines four classes — Class I, IIa, IIb, and III — each with different regulatory pathways and documentation requirements.
Our Medical Device Classification Tool guides you through a simple set of questions based on EU MDR rules, helping you determine your device’s classification with confidence.
✅ Key Benefits:
- Clarifies your device class under EU MDR rules
- Guides regulatory planning and compliance strategy
- Reduces risk of misclassification, saving time and resources
🔗 Click here to go to our Medical Device Classification Tool
🚀 Stay Ahead with Easy, Accurate Compliance
At Patient Guard, we know how overwhelming regulatory compliance can be — especially when you’re developing innovative products or entering new markets. That’s why we’ve created tools that are simple, smart, and aligned with EU MDR requirements.
Whether you’re:
- Launching a new product
- Seeking market entry in the EU
- Or refining your compliance strategy
Our software helps you move forward with confidence and precision.
📚 Frequently Asked Questions (FAQs)
This tool is ideal for manufacturers, developers, and startups who are unsure if their product falls under the scope of the EU MDR. It’s especially helpful during the concept or early design phase when compliance planning starts.
Our tools currently do not consider products that may fall into borderline categories. If your product has both medical and non-medical functions, you should seek professional opinion on how the combination product should be regulated.
The tools are designed to guide your compliance decisions, but they are not a substitute for a full regulatory assessment. For complex or high-risk products, we recommend combining the results with expert regulatory consulting — a service Patient Guard proudly offers.
We regularly review and update our software tools to ensure alignment with the latest EU MDR guidance, MDCG documents, and regulatory updates — so you can trust you’re getting current, relevant information.
🧭 Take the First Step Toward EU MDR Compliance Today
Don’t leave your compliance to chance. Use Patient Guard’s Medical Device Software Tools to:
- Understand your regulatory obligations
- Classify your device accurately
- Accelerate your path to market
📢 Get started now and take the first step toward smooth, stress-free regulatory compliance.
📞 Learn More About Patient Guard
Want expert support beyond our tools? Patient Guard offers full regulatory consulting services for medical devices and IVDs, helping companies like yours meet EU and UK requirements with confidence.
Visit PatientGuard.com to explore our services, or contact us to speak with a compliance expert.
