What is a “New Device” according to MDR and IVDR?
Introduction
The Medical Device Regulation (MDR, EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR, EU 2017/746) have significantly tightened the requirements for medical devices and in vitro diagnostics. In this context, the question arises: What qualifies as a “New Device” under MDR and IVDR? What criteria and regulatory requirements must manufacturers consider?
Definition of a “New Device” under MDR and IVDR
The terms “New Device” or “new medical device” are not explicitly defined in the MDR or IVDR. However, a medical device is considered “new” if it:
✅ Uses a completely new design or technology
✅ Has a new medical purpose or new indications
✅ Represents a fundamental modification of an existing product
✅ Is introduced to the European market for the first time
✅ Has not previously been classified under MDR or IVDR
🚫 Not considered a New Device:
❌ A product that has only minor changes to an existing design
❌ A simple update or modification of an approved medical device
❌ A product that already exists in a comparable version on the EU market
Examples of a “New Device”
Medical Devices under MDR:
- New implants with innovative material combinations
- Wearable medical technology with AI-powered health monitoring
- 3D-printed personalized prosthetics
- Robot-assisted surgical systems with new functionality
In Vitro Diagnostics under IVDR:
- Molecular diagnostic tests with new analysis technology
- Blood tests for previously undiagnosable diseases
- AI-based diagnostic software for personalized medicine
- Novel biomarker tests with higher sensitivity and specificity
Regulatory Requirements for a “New Device”
A new medical device is subject to strict approval and assessment procedures, especially if it does not fit into an existing product classification. The key requirements include:
1. Classification of the New Device
Medical devices are classified under the MDR into Class I, IIa, IIb, or III. A precise risk assessment is conducted for a “New Device.” The higher the risk, the stricter the regulatory requirements.
| Class | Risk Level | Example |
|---|---|---|
| I | Low | Digital thermometers |
| IIa | Medium | Electrosurgical instruments |
| IIb | High | Ventilators |
| III | Very High | Implantable pacemakers |
2. Clinical Evaluation and Performance Studies
Extensive clinical data is required for new medical devices, including:
- Clinical studies on safety and effectiveness
- Comparative data with existing products
- Performance studies for in vitro diagnostics under IVDR
3. Technical Documentation and CE Certification
Manufacturers must create comprehensive technical documentation as per Annex II and III of the MDR/IVDR, including:
- Product description and specifications
- Risk management file
- Evidence of biocompatibility and safety
- Instructions for use and labeling
4. Conformity Assessment and Notified Bodies
Depending on the classification of the New Device, a Notified Body is required to oversee the conformity assessment process.
- Class I: Self-certification by the manufacturer
- Class IIa, IIb, III: Notified Body reviews technical documentation, clinical data, and production processes
Challenges for Manufacturers of New Devices
📌 Longer approval timelines due to increased regulatory requirements
📌 Stricter evidence requirements for safety and performance verification
📌 Higher costs for clinical studies, conformity assessments, and post-market surveillance (PMS)
📌 Increased market surveillance through EUDAMED and UDI system
Conclusion
A “New Device” is a medical device or in vitro diagnostic that introduces novel technologies, indications, or material combinations and thus does not correspond to an existing device. These products are subject to comprehensive regulatory scrutiny, particularly in terms of risk assessment, clinical evidence, and technical documentation. Manufacturers must integrate MDR and IVDR requirements into their development strategies early to achieve market approval efficiently.
📌 Sources:
- Regulation (EU) 2017/745 on Medical Devices (MDR)
- Regulation (EU) 2017/746 on In Vitro Diagnostics (IVDR)
- MDCG Guidance Documents on Classification and Clinical Evaluation
- EUDAMED Database for Medical Devices
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