What is an “Active Device” according to MDR and IVDR?
Introduction
The Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746) have tightened the requirements for medical devices and in vitro diagnostics (IVDs) in Europe. One key classification concerns “Active Devices” (active medical devices). But what exactly are “Active Devices,” and what regulatory requirements apply to them?
Definition of an “Active Device” under MDR and IVDR
According to MDR (Article 2, Paragraph 4), an active medical device is defined as follows:
“An active medical device is any medical device whose operation depends on a power source other than that directly generated by the human body or gravity.”
The IVDR (Article 2, Paragraph 5) adopts a similar definition for active in vitro diagnostics (IVDs), focusing on devices that rely on electrical or other external power sources.
Characteristics of an Active Device
✅ Requires an external power source (e.g., electricity, battery, gas, compressed air).
✅ Actively converts energy or uses it for its function.
✅ Performs diagnostics, therapies, or monitoring.
✅ Directly influences the patient’s condition or processes biological samples.
🚫 Not classified as an Active Device:
❌ Products that operate only mechanically or by gravity (e.g., non-powered wheelchairs, simple scalpels, bandages).
❌ Passive medical devices that do not require an external energy source.
Examples of Active Devices
Medical Devices under MDR:
- Pacemakers
- Defibrillators
- Infusion pumps
- Ventilators
- Electronic blood pressure monitors
In Vitro Diagnostics under IVDR:
- PCR analyzers
- Automated blood analysis devices
- Electronic microscopes for laboratory analysis
- Software for diagnostic data processing
Classification of Active Devices under MDR
Active Devices are categorized based on their risk to the patient into the following risk classes:
| Class | Risk Level | Example |
|---|---|---|
| I | Low | Electronic thermometers |
| IIa | Medium | Electrosurgical instruments, infusion pumps |
| IIb | Higher | Ventilators, dialysis machines |
| III | High | Pacemakers, implantable defibrillators |
The higher the class, the stricter the regulatory requirements.
- Class I devices require only self-certification.
- Class II and III devices require CE certification through a Notified Body.
Regulatory Requirements for Active Devices
1. Technical Documentation
Manufacturers must provide detailed documentation on the safety, performance, and risk management of an Active Device, including:
- Electrical safety (according to IEC 60601 standards for medical devices)
- Electromagnetic compatibility (EMC regulations)
- Mechanical safety (protection against overheating, material failure)
- Biocompatibility and test reports
2. Software Requirements in Active Devices
Under the MDR, software solutions can also be classified as Active Devices if they:
- Support diagnosis or therapy decisions
- Actively process medical data (e.g., AI-assisted analysis)
- Provide patient monitoring functions
3. Traceability and UDI
Active Devices must be assigned a Unique Device Identification (UDI) number, which is registered in the EUDAMED database. This improves traceability and facilitates market surveillance.
Conclusion
An “Active Device” is a medical device that requires an external power source to function and actively influences the patient or diagnostic processes. These devices are subject to strict regulatory requirements under both the MDR and IVDR. Manufacturers must carefully address the classification, technical documentation, and certification of their products to ensure compliance with EU regulations.
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