Overview
Summary
Defining your device characteristics and determining its regulatory classification forms the foundation of your entire certification strategy. This critical step establishes your regulatory pathway, determines required documentation depth, and influences every subsequent decision in your medical device development process. Your device’s intended use statement and classification assignment directly impact timelines, costs, and market access requirements across both EU and US jurisdictions.
Regulatory Context
Under 21 CFR Parts 862-892 and Federal Food, Drug, and Cosmetic Act Section 513:
- Device classification determines Class I, II, or III assignment based on intended use and risk profile
- Product codes drive regulatory pathway selection (510(k), PMA, De Novo)
- Predicate device identification establishes substantial equivalence framework for Class II devices
- Intended use statements must align with FDA-cleared indications and clinical evidence
Special attention required for:
- Software medical devices - classification based on clinical decision-making impact, not technical complexity
- AI/ML algorithms - limited predicates available, may require De Novo pathway establishment
- Novel technologies - absence of appropriate predicates necessitates De Novo pathway consideration
- Combination products - each component requires separate classification analysis
Under 21 CFR Parts 862-892 and Federal Food, Drug, and Cosmetic Act Section 513:
- Device classification determines Class I, II, or III assignment based on intended use and risk profile
- Product codes drive regulatory pathway selection (510(k), PMA, De Novo)
- Predicate device identification establishes substantial equivalence framework for Class II devices
- Intended use statements must align with FDA-cleared indications and clinical evidence
Special attention required for:
- Software medical devices - classification based on clinical decision-making impact, not technical complexity
- AI/ML algorithms - limited predicates available, may require De Novo pathway establishment
- Novel technologies - absence of appropriate predicates necessitates De Novo pathway consideration
- Combination products - each component requires separate classification analysis
Under EU MDR 2017/745, Annex VIII and EU IVDR 2017/746, Annex VIII:
- Classification rules are mandatory and rule-based for medical devices (Class I, IIa, IIb, III)
- IVDR classification follows separate rules for in vitro diagnostics (Class A, B, C, D)
- Intended purpose drives Annex VIII rule application and conformity assessment procedures
- Notified body involvement required for higher classifications (IIb, III, IVDR C/D)
Special attention required for:
- Multiple rule applicability - strictest rule resulting in highest classification must be applied
- Software medical devices - Rule 11 classification based on clinical decision impact
- Active implantable devices - automatically Class III under Rule 9
- Companion diagnostics - typically IVDR Class C with extensive clinical performance requirements
Overview
Device characteristics and classification encompasses five interconnected tasks that establish your regulatory foundation. Your intended use statement serves as the cornerstone document that defines your device’s medical purpose, patient population, and clinical application scope. This statement drives all subsequent classification decisions and regulatory requirements, making its precision absolutely critical for successful certification.
Classification under FDA regulations focuses on product code assignment based on intended use rather than physical characteristics. Your product code determines whether you pursue 510(k) clearance, PMA approval, or De Novo pathway establishment. The classification process requires systematic evaluation of existing device categories and careful analysis of your device’s clinical application within established regulatory frameworks.
Predicate device identification becomes essential for Class II devices pursuing 510(k) clearance, as substantial equivalence forms the basis for FDA authorization. Your predicate selection influences required testing protocols, acceptable performance specifications, and regulatory review timeline. Multiple predicates may be necessary when no single device provides adequate technological or clinical comparison.
EU MDR classification follows a fundamentally different approach using rule-based analysis from Annex VIII. Your classification depends on intended purpose, invasiveness, duration of use, and body interaction characteristics. The systematic application of implementing rules determines your conformity assessment procedure and notified body requirements, with higher classifications demanding more extensive clinical evidence and quality management system compliance.
IVDR classification applies specifically to in vitro diagnostic devices using separate rules focused on clinical significance rather than physical characteristics. The classification considers the consequences of incorrect results on patient management, with companion diagnostics, genetic testing, and blood grouping typically requiring higher classifications and notified body involvement.
These classification decisions fundamentally shape your regulatory strategy because they determine the depth of clinical evidence required, the extent of quality management system compliance needed, and the timeline for market access. Higher classifications across both jurisdictions require more extensive documentation, longer review processes, and ongoing post-market surveillance obligations. Understanding these implications early in development allows for strategic planning of resources, timelines, and clinical development programs.
The interconnection between intended use and classification creates cascading effects throughout your certification process. Your intended use scope directly influences classification outcomes, which in turn determine your testing requirements, clinical evidence needs, and labeling obligations. Strategic decisions about intended use breadth must balance market access goals with regulatory burden and development timelines.
Software and artificial intelligence components add complexity to both intended use definition and classification processes. These technologies require careful analysis of clinical decision-making impact, algorithm validation requirements, and performance monitoring obligations. The evolving regulatory landscape for digital health technologies demands particular attention to guidance documents and precedent devices when establishing your regulatory approach.
Classification also affects your business model and market access strategy. Higher classifications typically require longer development timelines, more extensive clinical programs, and greater regulatory expertise. However, they may also provide stronger competitive protection and broader market applications. Understanding these trade-offs enables informed strategic decision-making during device development planning.