Essential Insights to Clearly Define the Intended Purpose of Multi-Function Devices
Defining the intended purpose of multi-function devices is not just a formality—it’s a regulatory requirement under the EU Medical Device Regulation (MDR). But more importantly, it’s a cornerstone for patient safety and successful device classification. When a console can operate multiple attachments, each with its own clinical application, the need for a precise and compliant intended purpose statement becomes non-negotiable.
Intended Purpose of Multi-Function Devices
The concept of intended purpose in MDR is more than a line in your technical documentation. It defines what the device is meant to do, who it’s for, how it’s used, and under what circumstances. MDR Article 2(12) states:
“‘Intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements, and as specified by the manufacturer in the clinical evaluation.”
That definition alone sets the tone. Everything—classification, conformity assessment, post-market surveillance—hinges on the clarity of this statement.
Why Intended Purpose Matters More for Multi-Function Systems
In a complex device system—such as an electrosurgical unit with several attachments—every functional configuration must be accounted for. The device’s purpose must cover both the core system and the attachments, with each configuration clearly aligned to its clinical application.
Imagine a console used for endoscopy, surgical coagulation, and ablation. Each function carries its own risks, clinical benefits, and regulatory classification. Misalignment or ambiguity in the intended purpose could lead to:
Wrong device classification
Delayed CE marking
Regulatory penalties
Safety incidents
And all of these have business consequences too.
Defining a Comprehensive Intended Purpose
To ensure compliance and clinical usability, follow these core elements:
Specify the Medical Field
Is the device for orthopedic, cardiovascular, neurological, or ENT use? Be specific.
Example: “The console is intended to power various surgical tools used in orthopedic and neurosurgical interventions.”
Clarify Configuration-Based Use
A conditional format works wonders.
Example: “When used in combination with Handpiece A, the system is intended for tissue ablation during arthroscopy.”
This phrasing links each accessory to its application, reducing ambiguity.
Define the User
Is it for professional, clinical staff or trained specialists?
Example: “Intended for use by licensed surgeons trained in minimally invasive techniques.”
Outline the Use Environment
Is the device for hospital operating rooms, outpatient clinics, or home care?
Example: “Designed for use in sterile environments such as hospital surgical suites.”
Establish Functional Outcomes
What should the device achieve?
Example: “Enables precision coagulation and tissue dissection with real-time feedback.”
Impact on Device Classification
Under MDR Annex VIII, device classification is risk-based. But when you bundle multiple functions, things get complicated. Each function must be classified independently.
Key Considerations:
Coagulation module: Class IIb (invasive energy-based)
Imaging module: Class IIa (diagnostic)
Navigation module: Class I (non-invasive software)
Mixing these without clear segmentation in your intended purpose will confuse the Notified Body—and could delay approval.
Pro tip: Treat each function like a mini-device. Assess them separately, then integrate the risk analysis under a unified system-level technical file.
Accessories and Their Role in Intended Purpose
Accessories are often misunderstood. MDR defines them as:
“An article which, while not being a device itself, is intended to enable a device to be used in accordance with its intended purpose.”
The key word is enable. Not optional, not decorative—functional.
Example Accessory Statement:
“The bipolar forceps are an accessory designed to enable electrosurgical coagulation in conjunction with the base unit.”
Misclassifying accessories can lead to regulatory flags. They often require their own CE mark, risk classification, and safety data.
Examples of Well-Written Intended Purpose Statements
| Device Type | Intended Purpose |
|---|---|
| Surgical Console | For powering and controlling modular surgical tools in orthopedic, gynecological, and neurosurgical procedures in a sterile environment. |
| Imaging Attachment | When connected to the console, provides real-time endoscopic imaging for diagnostic and interventional procedures in ENT surgeries. |
| Coagulation Tool | When paired with console Model X, enables high-frequency coagulation of soft tissue during laparoscopic interventions. |
These examples demonstrate specificity, context, and clarity.
Common Pitfalls to Avoid
Too Generic: “This device is for surgical use.” (Too vague.)
No Conditional Logic: Fails to specify what happens when the device is used with or without certain attachments.
Confusing Accessory Roles: Listing accessories as independent devices or vice versa.
Mismatch Across Documents: Discrepancies between IFU, labels, and marketing materials.
Clinical Evaluation and Intended Purpose Alignment
Your clinical evaluation report (CER) must back every word in your intended purpose. If you claim your device is “for real-time imaging in critical care,” your CER better include:
Literature review
Benchmarking against equivalent devices
Risk-benefit analysis
Clinical investigation or performance data
The intended purpose must appear in Annex XIV, Part A of your CER—and must match what’s on the label, in the IFU, and in your PMS documentation.
FAQs
What is the intended purpose under MDR?
It’s the official description of what the device is supposed to do, who it’s for, and how and where it should be used, according to the manufacturer.
How does the intended purpose affect classification?
Each function within a device must be assessed for risk individually, based on its intended purpose. This determines the risk class under MDR.
Can an accessory have its own intended purpose?
Yes. Accessories must be described in terms of how they enable the device to function as intended and must meet separate regulatory requirements.
Why is conditional phrasing important for multi-function devices?
It allows you to define purposes based on combinations of components, ensuring each configuration is correctly assessed.
How detailed should the intended purpose be?
It must include the medical indication, user type, use environment, functional outcome, and device interaction. Vagueness is non-compliant.
What documents should align with the intended purpose?
IFU, labels, marketing brochures, clinical evaluation, and PMS plans must all reflect the exact intended purpose statement
Final Thoughts
A clearly defined intended purpose for multi-function devices is not just a box to tick. It’s the thread that runs through your entire technical documentation—from classification and risk assessment to clinical data and market approval. It also directly impacts how your device is used—and how safely.
By making your intended purpose transparent, modular, and clinically grounded, you pave the way for:
Faster approvals
Easier audits
Improved patient outcomes
Lower regulatory risk
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✌️ Peace,
Hatem Rabeh, MD, MSc Ing
Your Clinical Evaluation Expert & Partner
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