European Medical Device Classification
The correct answer is B: Europe classifies medical devices as Class I, IIa, IIb, and III. 1, 2
Classification Structure
The European Union employs a four-tier risk-based classification system for medical devices that differs fundamentally from other regulatory frameworks 1, 2:
- Class I: Lowest risk devices (surgical instruments, some diagnostic devices) 2
- Class IIa: Low-to-moderate risk devices 1, 2
- Class IIb: Moderate-to-high risk devices 3, 2
- Class III: Highest risk devices (pacemakers, breast implants, most invasive devices) 2, 4
Risk-Based Determination
Classification is determined by the degree of risk the device presents to patients and users, with regulatory control and scrutiny increasing progressively from Class I through Class III 1, 2. The manufacturer specifies the intended purpose, technical specifications, and indications for use, which are then evaluated against these risk categories 5.
Regulatory Implications
- Class I devices typically require the least regulatory oversight 2
- Class IIa and above require involvement of EU-approved Notified Bodies for CE marking under the Medical Device Regulation (MDR) implemented in 2021 2, 4
- Class IIb and III devices face the most stringent requirements, including enhanced clinical evaluation, post-market surveillance, and clinical follow-up 3, 4
Contrast with US System
This differs markedly from the United States FDA system, which uses only three classes (I, II, and III) without the intermediate IIa and IIb subdivisions 5. Most diagnostic imaging systems in Europe are classified as intermediate-risk Class II devices 5.