Why Intended Purpose is the Most Critical Decision in Medical Device Development

Introduction

Many medical device projects fail because one foundational decision was left too late. 

The intended purpose determines what evidence you need, what claims you can make, and often how your device is classified. When it’s vague, overly broad, or misaligned with the supporting data, everything downstream becomes harder. Technical file reviews slow down. Non-conformities appear. Teams are forced into late-stage remediation that is costly, time-consuming, and entirely avoidable. 

This is why misalignment between intended purpose, claims, and documentation remains one of the most common causes of non-conformities during regulatory review. 

Why Intended Purpose Sets the Evidence Boundary

The intended purpose defines the scope of clinical evaluation, the claims you may make, and often the device’s risk classification. Misalignment between claims and documentation is one of the most common causes of non-conformities during technical file review. 

It sets the evidence boundary for performance and safety. A broad intended purpose increases the evidence burden across indications, populations, and use scenarios. If clinical planning starts late, remediation becomes costly and time consuming. 

A Pre-Submission “Sanity Check” for Any Device

While the intended purpose can range from straightforward to complex, the following pre-submission checklist applies to all devices: 

1. Intended purpose: Is it specific enough to be defensible, and does it match what you actually investigated and validated? 
2. Clinical benefit: Have you stated benefit clearly (direct or indirect), including for accessories where relevant? 
3. Claims control: Do your labels, IFU, and website claims stay inside what your conformity assessment and evidence support (MDR Article 7)? 
4. State of the art: Have you defined a meaningful benchmark for your specific scope, and is it objective? 
5. Classification rationale: Did you apply Annex VIII rules correctly, and choose the strictest applicable rule? 
6. Software (if applicable): Does Rule 11 apply, and have you aligned to MDCG 2019-11 for qualification and classification reasoning? 
7. Consistency: Is intended purpose, indications, contraindications, and warnings consistent across the technical file, CER, IFU, and Declaration of Conformity? 

Engage early: If anything is borderline or high impact, plan a structured dialogue with your notified or approved body rather than guessing. 

Claims Discipline and MDR Article 7

Under MDR Article 7, claims must not mislead or suggest uses beyond the assessed intended purpose. Marketing language that exceeds the evidence base invites scrutiny from notified bodies. 

When evidence supports a narrower statement, tighten the intended purpose rather than stretch claims. 

Clinical Benefit and Endpoints

State the clinical benefit explicitly and indicate whether it is direct or indirect. Regulators expect a clear chain: 

Intended purpose → claimed clinical benefit → endpoints or benchmarks → evidence 

Define measurable endpoints early so the clinical plan remains focused and defensible. 

State of the Art and Benchmarking

“State of the art” means benchmarking against accepted practice and knowledge, not asserting superiority. 

Let the data define the comparison set and scope. Avoid forcing an idealised narrative before the evidence is assembled. 

Classification Logic and Annex VIII

Classification is governed by intended purpose and Annex VIII rules. When multiple rules apply, the strictest applicable rule should be used. 

Document the rule-by-rule rationale and supporting evidence, as notified bodies may challenge the proposed classification. 

• Under-classification can trigger non-conformities if the evidence does not meet the true class expectations. 

• Over-classification can raise the bar unnecessarily, increasing clinical and evidence burden beyond what is required. 

Example:
Annex VIII Rule 18 classifies devices using non-viable tissues or cells of human or animal origin (or their derivatives) as Class III, unless the device is intended to contact intact skin only. 

This means a seemingly simple product concept can jump risk class based on materials and contact conditions, and the classification justification must show those triggers were considered. 

Software, Rule 11, and Borderline Cases

Software classification depends on what the software does to data. Under Rule 11, software that informs diagnostic or therapeutic decisions typically escalates in classification. 

For products on the medical device / IVD boundary, use the Borderline Manual and record a structured rationale. 

MDCG 2019-11 (rev.1) expands on qualification and classification for medical device software, including apps and cloud deployments. It reinforces that classification depends on intended purpose and clinical impact, not deployment location. 

Consistency Audit Across the Technical File

Ensure that intended purpose, indications, contraindications, warnings, IFU, clinical evaluation, and Declaration of Conformity all tell the same story. 

When documents diverge, notified bodies will usually ask for reconciliation. That reconciliation always costs time. 

Final Takeaway

The best way to avoid late-stage remediation is to treat intended purpose, clinical benefit, and classification as design inputs. 

When those fundamentals are nailed early, everything downstream (including clinical evaluation, labelling, and regulatory review) becomes simpler, faster, and far more defensible.