Your device’s intended purpose is where it all starts. It is not a device description, nor should it include legal or scientific elements to describe limitations or state-of-the-art. The EU IVDR 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 or as specified by the manufacturer in the performance evaluation.”  

Every intended purpose is strongly linked to the device classification and to the clinical evidence. There are two scenarios IVD manufacturers must be aware of:  

• The claims in the intended purpose are used by authorities or Notified Bodies to determine the correct classification according to IVDR classification rules. This is typically the first assessment made by a Notified Body when reviewing a CE Marking application. They check every detail in the intended purpose requirements (IVDR Annex I 20.4.1.c) and verify the classification and classification codes for the application. They cannot move forward with the application if one is missing or unclear.  

• Every claim made in the intended purpose must be verified through clinical evidence, which means in the scientific validity, analytical performance, and clinical performance, as applicable. This means that changes in the intended purpose might require significant revisions to scientific validity, analytical testing, or clinical performance studies.  

How intended purpose requirements changed under the IVDR

The new structure of the IVDR, which introduced implementing and classification rules for IVDs, defines detailed criteria for the intended purpose (IVDR Annex I 20.4.1.c). Many IVD manufacturers struggle to transition from a broad and analytical intended purpose, which they have applied for many years following IVDD, to a clearly defined intended purpose under IVDR. Here is an example:

Under IVDD:

The IVD test is intended to measure parameter x in human plasma. For professional use only.

Under IVDR:

The IVD test is an automated test to measure parameter x in human EDTA plasma on the analyzer XYZ. The IVD test is intended to be used for human patients in the age range of 18 to 65 years for screening of lung cancer. The test is not intended to be used for diagnosis or staging of cancer. For professional use only.  

To elaborate, if there is automated use, this must be specified and the automation should be named, and the verification and validation testing should be provided in the Technical Documentation. Specific indications or target groups of patients and the indication for the claimed diagnosis should be defined. These indications are the input for the scientific validity search, the identification of similar devices, the final analytical and clinical performance testing, and updates on labelling and promotional material. Consequently, a change of intended purpose may require IVD manufacturers to update significant parts of their Technical Documentation (Performance Evaluation).  

For clinical evidence, we often see clinical performance studies or clinical testing with an “old” intended purpose (analytical focused) that does not address the intended purpose criteria under IVDR. Can these be accepted for CE Marking under IVDR? Remember that you as a manufacturer need to provide the evidence for meeting your claims as defined in your intended purpose. Regulators will audit you for these elements and assess the clinical evidence reflected in your performance evaluation report.

The long-term impact of your IVD’s intended purpose

Intended use changes can also have long-term business impacts. They can reduce the application of your IVD in the clinical routine because clinicians or physicians are only allowed to use CE-marked devices under the claims defined by the IVD manufacturer. Off-label use must be verified and justified by the clinician and then falls under the responsibility of the laboratory, not the IVD manufacturer.  

In sum, it is particularly important to address the changes in the intended purpose from the beginning of your IVDR transition. There could be significant impacts on the classification and application of transitional timelines, which depend on the correct classification. Well-structured planning keeps the new documents required for the Technical Documentation under IVDR more consistent and prevents double work through changes and updates.  

Pure Global can help you define your intended purpose for IVDR CE Marking, understand the link between intended purpose and IVDR elements, and perform a classification assessment for your IVD according to IVDR rules. Learn more about our EU IVDR Classification support.

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