Under the European Medical Device Regulation (EU MDR 2017/745) and In-Vitro Diagnostic Regulation (EU IVDR 2017/746), the “Intended Purpose” is the most critical element of your technical file. It defines the scope of your CE marking and dictates the level of clinical evidence required for market access.

In the EU, “Intended Purpose” is the legally recognized term that encompasses what the device does and who it is for.

MDR 2017/745 Article 2(12) defines Intended Purpose as:

“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.”

IVDR 2017/746 Article 2(12) defines Intended Purpose as:

“For IVDs, the definition is similar but focuses on the performance evaluation and the specific analytes the device is intended to detect or measure”

The Intended Use is a high-level statement that establishes the boundaries of the device’s legal manufacture. It must address:

• Medical Objective: (e.g., diagnosis, prevention, monitoring, treatment).

• Patient Population: (e.g., age groups, weight, gender).

• Intended User: (e.g., healthcare professional, layperson).

• Environment: (e.g., hospital, home use, sterile environment).

Examples of Intended Use Statements for MDR : Hemodialysis Tubing

• Statement: A sterile single-use blood tubing set intended for use with hemodialysis systems for extracorporeal blood circulation during hemodialysis treatment in adult patients with renal failure.

Examples of Intended Use Statements for IVDR : Dengue Antigen Assay

• Statement: A rapid immunochromatographic assay intended for the qualitative detection of Dengue NS1 antigen in human serum to aid in the diagnosis of Dengue infection.

While not defined as a standalone term in MDR/IVDR Article 2, Indications for Use provide the clinical “When” and “Why.” They offer granular detail that supports the broader Intended Use.

Comparative Examples

At I3CGLOBAL, we frequently see manufacturers struggle with Notified Body (NB) non-conformities due to vague intended purpose statements.

Impact on Device Classification

Your intended purpose directly triggers the classification rules in Annex VIII (MDR) or Annex VIII (IVDR). A broad statement can inadvertently move a Class IIa device into Class III, significantly increasing costs and timelines.

Risks of Poorly Defined Statements

• CER/PER Rejection: If the Clinical Evaluation Report does not provide data for every claim in the Intended Use, the NB will issue a major non-conformity.

• Marketing Restrictions: You cannot promote a device for a “use” that is not explicitly stated in your technical documentation.

• Audit Delays: Any mismatch between the IFU, Label, and Technical File will halt the CE certification process.

To qualify technical documentation from a Notified body manufacturers must ensure absolute consistency across all documentation. This “Intended Use” links the initial design to the final marketing claim.

• Label & IFU: Must match the Technical File.

• Risk Management: Must address hazards for the specific intended environment.

• Clinical Evaluation (CER/PER): Must prove safety and performance for the stated indications.

• PMS & PMCF: Post-market activities must monitor the device within its intended use scope.

• Manufacturer’s Website: Should match with IFU and Technical Documentation File