The European regulatory landscape has significantly changed over the past 10 years, particularly concerning requirements for Clinical Evaluation (CEP/CER). The definition of intended purpose has evolved, and manufacturers must now ensure their Instructions for Use (IFU) clearly communicate the device's intended purpose, clinical benefits, indications, conditions of use, and contraindications—all supported by robust clinical evidence.
The Evolution of Intended Purpose: From MDD to MDR
The definition of intended purpose has undergone significant refinement across regulatory frameworks. Understanding this evolution is critical to ensuring your IFU meets current MDR requirements.
MDD (93/42/EEC) Definition
Article 2 of the MDD states: "Intended purpose was defined by Article 1(2)(g) as 'the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.'"
MDR 2017/745 Definition
In the MDR 2017/745, intended purpose means, according to definitions in Article 2: "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."
This expanded definition emphasizes that the intended purpose must be consistently communicated across all manufacturer materials and must be substantiated by clinical evaluation. The IFU is now a critical regulatory document that bridges the clinical evidence and user expectations.
MDR Requirements for Clinical Evaluation and IFU
The requirements from Article 61 and Annex XIV of the EU MDR, with additional clarifications provided by guidance such as MDCG 2020-5 and 2020-6, specify that the clinical evaluation must:
- Clearly identify the intended purpose and associated clinical benefits of the device(s) as well as the conditions of use and specific contraindications
- Ensure that available clinical evidence can justifiably support all claims made in the IFU
- Establish outcomes achievable with other state of the art (SOTA) therapies for the same patient populations and treatment indications
- Determine benchmarks for safety, performance, and benefit-risk of the subject device
- Define measurable parameters and associated objectives/endpoints
- Specify acceptable outcomes and performance measures
It is essential to identify these parameters to demonstrate that a medical device achieves its intended purpose, clinical safety, and benefits. The manufacturer needs to state how those parameters can be measured or indicated (i.e., what the associated objectives/endpoints are), and what acceptable outcomes look like (i.e., similar benchmarks or performance measures).
Defining Intended Purpose: The Foundation of IFU Compliance
To do this, it is necessary to start with a clear and comprehensible description of the medical device's intended purpose, indications, and a specification of the standard of care for that intended purpose (state of the art).
The definition of the intended purpose and indications for use of the device is a fundamental step that describes all the following aspects of the clinical evaluation and directly impacts IFU compliance.
What Intended Purpose Helps Define:
- The target patient population and clinical condition
- The clinical benefits and therapeutic outcomes
- Conditions of use (e.g., setting, operator qualifications, patient characteristics)
- Contraindications and warnings
- Performance expectations and safety parameters
- Relevant clinical evidence requirements
Indications vs. Intended Purpose: Critical Distinction
Although Article 2(12) of the MDR provides the same definition of "intended purpose" as the former Directives, Annex I Section 23.4 confirms that the intended purpose includes indications, where these exist.
Important Note on Indications
Not all devices have indications, as clarified by the definition in MDCG 2020-6: "Indication" or "indication for use" refers to the clinical condition to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified, or controlled by the medical device. It should be distinguished from "intended purpose/intended use," which describes the effect of a device. All devices have an intended purpose, but not all devices have an indication (e.g., medical devices with an intended purpose of disinfection or sterilization of devices).
What Your IFU Must Contain
Under MDR compliance, the IFU should contain all the following points:
| IFU Element | Description & Compliance Requirement |
|---|---|
| Intended Purpose | Clear statement ofthe device's intended use, clinical benefits, and target population |
| Indications for Use | Clinical conditions the device is designed to diagnose, treat, monitor, or alleviate (if applicable) |
| Contraindications | Patient populations or clinical conditions where the device should NOT be used |
| Conditions of Use | Specific settings, operator qualifications, patient characteristics, and usage parameters |
| Safety Information | Warnings, precautions, and adverse events based on clinical evidence |
| Performance Data | Clinical benefits, efficacy, and performance metrics supported by clinical evidence |
| Instructions for Use | Step-by-step guidance on proper device use, maintenance, and storage |
| Labeling Claims | All marketing and promotional statements must align with clinical evaluation |
Avoiding Misleading Claims in IFU and Labeling
Article 10(2) of the MDR explicitly states:
"In the labelling, IFU, making available, putting into service and advertising of devices, it shall be avoided to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient related to the intended purpose, safety and performance of the subject device."
This means that every statement in your IFU must be:
- Supported by clinical evidence from your Clinical Evaluation Report (CER)
- Accurate and not exaggerated
- Clear and comprehensible to the intended user
- Consistent across all manufacturer communications (labeling, promotional materials, website)
- Compliant with MDCG guidance on permissible claims
Clinical Data Requirements for Indications
If a device has indications, confirmation of conformity with the relevant General Safety and Performance Requirements (GSPRs) of Annex I must include clinical data relating to these indications.
Key Compliance Point
Every indication stated in the IFU must be supported by clinical data demonstrating that the device achieves its intended purpose for that specific clinical condition. Broad or unsupported indications will not satisfy MDR requirements.
Annex XIV Section 1a specifies that the clinical evaluation plan must include:
- A systematic review of the clinical literature relevant to the device and its indications
- Clinical investigations or performance evaluation studies
- Post-market surveillance data and real-world evidence
- Comparative analysis with state-of-the-art therapies
- Risk-benefit analysis specific to each indication
Why Broad Intended Purpose Statements Are Insufficient
It is important to note that broad intended purpose statements will not be satisfactory for most devices under the MDR. Regulators and notified bodies expect specificity that allows for meaningful clinical evaluation and user understanding.
Example: Stating "for general wound care" is too broad. Instead, specify: "for management of chronic venous leg ulcers in patients aged 18-85 with adequate perfusion (ABI ≥0.8)."
Specificity in your intended purpose statement:
- Enables precise clinical evaluation
- Supports regulatory approval and notified body assessment
- Reduces post-market compliance risks
- Improves user understanding and safe device use
- Facilitates post-market surveillance and PMCF planning
IFU Compliance Checklist for MDR
- Intended purpose is clearly stated and specific, not broad or vague
- All indications are explicitly listed and supported by clinical evidence
- Contraindications are comprehensive and evidence-based
- Conditions of use specify target population, setting, and operator qualifications
- Safety information (warnings, precautions, adverse events) aligns with clinical data
- Performance claims are quantified and supported by clinical evidence
- All labeling and promotional statements are consistent with IFU and CER
- No misleading or exaggerated claims are present
- IFU is written in clear, comprehensible language for the intended user
- IFU has been reviewed and approved by regulatory and clinical teams
- IFU is included in the technical documentation file
- IFU is regularly updated as new clinical data becomes available
Key Takeaways
- Intended purpose is the cornerstone of IFU compliance under MDR 2017/745
- The IFU must clearly communicate intended purpose, indications, contraindications, and conditions of use
- Every claim in the IFU must be supported by clinical evidence from your Clinical Evaluation Report
- Broad intended purpose statements are insufficient; specificity is required
- Not all devices have indications, but all devices have an intended purpose
- Misleading or exaggerated claims in IFU, labeling, or promotional materials violate MDR Article 10(2)
- Clinical data requirements differ based on device classification and indications
- IFU compliance is an ongoing responsibility requiring regular updates as new evidence emerges
- Notified bodies assess IFU compliance as part of the conformity assessment procedure
- Post-market surveillance and PMCF planning should align with the stated intended purpose and indications
Conclusion
Your Instructions for Use are far more than a user manual—they are a critical regulatory document that bridges clinical evidence, intended purpose, and user safety. Under MDR 2017/745, ensuring IFU compliance requires careful attention to specificity, evidence-based claims, and clear communication of intended purpose, indications, and contraindications.
At Eclevar MedTech, we understand the complexities of MDR compliance, including the intricate relationship between clinical evaluation, intended purpose definition, and IFU development. Our team of regulatory and clinical experts can help you navigate these requirements, ensuring your IFU meets all MDR standards while effectively communicating your device's benefits and safe use to users.
Ready to ensure your IFU is fully MDR compliant? Contact our team to discuss your specific device and regulatory needs.
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