Regulatory Affairs Bulletin: Intended Purpose vs Intended Use under MDR & IVDR

European regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) require precise definitions in technical documentation, and the distinction (or overlap) between intended purpose and intended use remains a topic of operational significance. This bulletin clarifies the regulatory definitions, their implications, and guidance interpretations.

Definitions under MDR & IVDR

MDR (EU 2017/745), Article 2(12):

“‘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.” (MDR)

IVDR (EU 2017/746), Article 2(12):

“‘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 or as specified by the manufacturer in the performance evaluation.” (IVDR)

Key Takeaway: Intended purpose is a legal term. It is the manufacturer’s declared scope of what the device is meant to do, forming the foundation for regulatory classification, clinical evaluation, and conformity assessment.

Intended Use:

The term intended use is not explicitly defined in either MDR or IVDR. Regulatory and standards-based documents commonly treat intended use as a synonym of intended purpose. For example, the Medical Device Coordination Group guidance MDCG 2020-6 states:

“The MDR defines ‘intended purpose’, but not ‘intended use’. ‘Intended use’ should be considered to have the same meaning as ‘intended purpose’.” (MDCG 2020-09) Also, international standards such as ISO 14971:2019 use “intended use/intended purpose” interchangeably, with notes identifying typical elements (patient population, mode of action, environment, etc.).

In practice, intended use is often interpreted as the clinical or practical application of the device: how, where, and by whom the device is meant to be used. For example:

§  A diagnostic assay’s intended purpose may be “qualitative detection of virus X in human serum,” while its intended use specifies whether it is for professional laboratory use or point-of-care testing.

§  A surgical instrument’s intended purpose may state it is “for cutting tissue,” while intended use clarifies the clinical context, such as “for laparoscopic abdominal surgery.”

Key Takeaway: Intended use reflects the practical deployment of the device, often with more granularity than the legally binding intended purpose or it is used as a synonym of intended purpose.

Key Regulatory Implications

• Classification:
  Under IVDR Annex VIII (classification rules), the intended purpose specified by the manufacturer is the controlling basis for assigning a device’s risk class. Ambiguities or broad statements can lead to higher class assignments.
• Clinical / Performance Evaluation:
  MDR requires that clinical evaluation verify safety and performance, “when used as intended by the manufacturer,” which ties back to the declared intended purpose. IVDR similarly requires performance evaluation consistent with intended purpose.
• General Safety and Performance Requirements (GSPRs):
  The GSPRs in Annex I of both MDR and IVDR refer to “intended purpose” in respect of safety, design, usability, labeling, etc. All downstream documentation (e.g. IFU, promotional materials) must align with that purpose. Inconsistency may result in non-compliance.
• Avoiding Misleading Claims & Liability:
  Article 7 MDR / IVDR prohibits misleading information; if promotional materials or claims exceed or differ from the declared intended purpose, this may violate regulatory obligations.

Best Practices for Regulatory Affairs Professionals

From the definitions and guidance, the following practical recommendations emerge:

Definition & Documentation

Define the intended purpose early in product development; Use the wording of MDR/IVDR Article 2(12) as baseline.

Consistency

Ensure intended purpose is consistent across all documents: label, IFU, promotional material, clinical or performance evaluation, technical file (Annex II). Any divergence may be treated as an unapproved claim or misrepresentation.

Clarity vs Flexibility

Be specific enough to allow correct classification, risk assessment and evidence generation, while allowing legitimate future expansion (if desired) without excessively restrictive wording.

Use of “Intended Use”

Although not defined, when using “intended use” internally or in standards, clarify that it is equivalent to intended purpose. Avoid using “intended use” in ways that imply extended or additional functions beyond what is declared in intended purpose.

Claims & Marketing

Review promotional materials carefully to ensure they do not introduce new intended purposes or uses not supported by clinical/performance evidence. If use cases outside the stated purpose are foreseeable, include limitations in IFU and technical documentation.

Summary

• Intended purpose is a legal term explicitly defined in both MDR (Art. 2(12)) and IVDR (Art. 2(12)); intended use is not defined but is commonly treated as synonymous with intended purpose.
• The declared intended purpose drives critical regulatory outcomes: classification, conformity assessment, clinical/performance evaluation, labelling, and marketing claims.
• Regulatory strategy must ensure that all documentation aligns with the same intended purpose, and that any “use” beyond that purpose is either excluded or appropriately supported and declared.