Medical Device Classification Services
Medical Device Classification Services | Device Regulatory Evaluation & Pathway Assessment
Get Expert Device Classification & Evaluation
Specialist medical device classification services for pharmaceutical and medical device companies — delivered by RABT Global’s expert regulatory team.
Medical device classification services are the critical first step in any device regulatory programme. Incorrect device classification can derail an entire regulatory strategy — leading to wrong submission pathways, inadequate clinical data plans, and ultimately, regulatory failure. At RABT Global, our device classification consulting team provides expert regulatory device evaluation services across all major regulatory frameworks — helping device manufacturers establish the correct classification, identify the appropriate conformity assessment route, and build a regulatory strategy on firm foundations.
Our Device Classification & Evaluation
Comprehensive device classification services across all major regulatory frameworks.
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FDA Device Classification
Rule of Thumb and 513(g) classification determination for Class I, II, III devices
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EU MDR Device Classification
Annex VIII rule-based classification for Class I, IIa, IIb, III devices
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EU IVDR IVD Classification
Class A, B, C, D classification for in vitro diagnostic medical devices
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UK MHRA Device Classification
Classification under UK MDR 2002 (amended) for GB market access
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GCC Device Classification
Classification requirements for UAE MOHAP, Saudi SFDA, and other GCC markets
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Medical Device Regulatory Pathway Evaluation
Submission pathway assessment (510(k), PMA, CE marking, etc.)
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Combination Product Classification
FDA product jurisdiction determination and combination product regulatory strategy
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Device Borderline Assessment
Assessing whether a product is classified as a medical device, drug, or cosmetic
How RABT Global Delivers This Service
Our proven five-step process ensures consistent, high-quality regulatory outcomes.
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Step 1: Initial Consultation & Needs Assessment
We review your specific medical device classification services requirements, target markets, and timelines to scope the engagement.
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Step 2: Strategy & Planning
Our specialist team develops a tailored approach aligned with applicable regulatory requirements and your commercial objectives.
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Step 3: Delivery & Execution
We execute the defined scope — producing regulatory-compliant deliverables to the highest quality standards.
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Step 4: Review & Quality Assurance
All deliverables undergo independent review and quality check before client delivery.
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Step 5: Ongoing Support
RABT Global remains available for follow-up queries, regulatory authority interactions, and lifecycle support.
What are Device Classification & Evaluation?
Device Classification & Evaluation provide life sciences companies with specialist medical device classification services expertise — supporting regulatory compliance, market access, and product lifecycle management across pharmaceutical and medical device sectors. RABT Global’s medical device classification services are delivered by qualified regulatory professionals with deep expertise in FDA, EMA, MHRA, CDSCO, and global regulatory requirements.
Device Classification & Evaluation — FAQs
Under EU MDR 2017/745, medical devices are classified as Class I (lowest risk), Class IIa, Class IIb, or Class III (highest risk) based on 22 classification rules in Annex VIII. These rules consider factors including invasiveness, duration of contact, anatomical location, and whether the device uses a biological or active principle. RABT Global’s EU MDR device classification service applies these rules systematically — with documented justification for your technical file.
An FDA 513(g) request is a formal mechanism for asking the FDA to confirm the classification of a device type that you believe is not already classified or where classification is uncertain. It is useful for novel devices, borderline products, or where you need documented FDA confirmation of classification before proceeding to submission. RABT Global’s FDA device classification support includes 513(g) request preparation and management.
RABT Global combines specialist medical device classification services expertise with a proven track record across 200+ global clients. Our regulatory team brings multi-jurisdictional knowledge, integrated regulatory and medical writing capabilities, and a genuine partnership approach — making us the medical device classification services provider of choice for pharmaceutical and medical device companies worldwide.
Why Trust RABT Global
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Qualified regulatory professionals across all major regulatory disciplines
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500+ successful regulatory submissions across pharma and medical devices
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200+ global client organisations served across 40+ countries
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ISO-aligned quality management systems for all regulatory deliverables
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Transparent project management with dedicated named account manager
Expert Device Classification & Evaluation — Partner with RABT Global
Get specialist medical device classification services from RABT Global’s expert regulatory team. Trusted by 200+ life sciences companies worldwide.
