MDR versus FDA classification
Understanding Medical Device Classification Systems
When developing medical devices for global markets, regulatory compliance is essential. One of the first critical steps in the development process is determining the device classification, which directly influences the regulatory pathway, documentation requirements, and time-to-market. The European Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA) follow different frameworks for classifying devices, making it crucial for manufacturers to understand the distinctions and their implications.
Different Systems, Same Goal: Ensuring Safety and Performance
Both MDR and FDA classification systems are risk-based, meaning that higher-risk devices face more rigorous scrutiny. However, the way risk is assessed and the consequences for regulatory planning differ significantly.
FDA Classification System (USA)
The FDA assigns devices into different classes:
- Class I – Low risk; typically exempt from premarket review.
- Class II – Moderate risk; requires 510(k) submission to prove equivalence.
- De Novo (Class II) – Used when no suitable predicate exists; creates a new classification.
- Class III – High risk; requires a Premarket Approval (PMA) with supporting clinical data.
The FDA’s classification is based on intended use and technological characteristics.
MDR Classification System (Europe)
Under the EU MDR (2017/745), devices are categorized into Class I, IIa, IIb, or III, with strict classification rules based on factors such as:
- Degree of invasiveness
- Duration of use
- Body part affected
- Active vs. non-active function
Unlike the FDA, MDR classifies devices using a rule-based approach, with Annex VIII providing 22 classification rules. These rules result in more nuanced and often stricter classifications, particularly for software, reusable surgical instruments, and implantable devices.
Impact on Regulatory Strategy
The classification under MDR or FDA has a direct effect on preclinical and clinical testing requirements, documentation and technical file content, submission complexity and timelines, involvement of third parties (e.g., Notified Bodies or FDA reviewers).
For example, a device that may be Class II under FDA and subject to 510(k) clearance might be considered Class III under MDR, requiring a Notified Body review and potentially clinical investigation.
Strategic Considerations for Global Market Access
Given these differences, manufacturers must carefully assess the regulatory implications of their product classification in each region. Early regulatory planning is essential to avoid delays or redundant testing.
At GBA Group, we guide medical device developers through both MDR and FDA regulatory frameworks, offering clarity in classification, support in submission preparation, and strategic advice to align development with regional requirements.
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