Intended Purpose, Qualification, and Classification of Medical Devices Under the MDR and IVDR

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The intended purpose of a medical device is the first regulatory determination for a project. It describes what a product is intended for according to the manufacturer’s specifications and is documented in the label, instructions for use, and promotional materials. This initially determines the qualification, that is, whether a product falls within the scope of Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Only then does classification follow—that is, the assignment to a risk class in accordance with Annex VIII of the MDR or Annex VIII of the IVDR.

This sequence has practical implications. It determines whether a Notified Body is involved, the scope of the clinical evaluation or performance evaluation, and the expected duration and costs. It also affects product design and potential reimbursement pathways. This article outlines the three steps and describes how they interact.
 

Intended purpose: Definition and scope

The intended purpose is defined in Art. 2(12) of the MDR and Art. 2(12) of the IVDR. The decisive factor is the use for which a product is intended according to the manufacturer’s specifications. These specifications are also derived from the Label, the instructions for use, and the advertising and sales materials.

Two aspects follow from this: first, the intended purpose is not an internal note but an outward-facing statement. Second, marketing communications are part of this statement. Statements in product descriptions, app store texts, or sales materials that go beyond the documented intended purpose can alter a product’s regulatory status.

A robust intended purpose typically designates the medical purpose, the target population, the indication, the intended user group, the application environment, and the body part or tissue with which the product comes into contact. For in vitro diagnostic medical devices (IVDs), additional details are required: the analyte, the sample material, the purpose of the test (such as screening, diagnosis, or monitoring treatment), the type of result (qualitative or quantitative), and whether the product is intended for laboratory use, for near-patient testing, or for self-testing.
 

Distinction between intended purpose and intended use

In “practical usage,” a distinction must be made between the “intended purpose” and the “intended use” of a product, insofar as the latter describes the specific, proper application within the scope of the intended purpose. While the MDR and IVDR define “intended purpose” as a legal term, “intended use” is not defined independently in the same way. The terms are sometimes used interchangeably.

The intended purpose establishes the regulatory framework: It describes the medical use for which the product is intended according to the manufacturer’s specifications. This information is derived in particular from the label, instructions for use, advertising and sales materials, or corresponding statements, as well as from the clinical evaluation under the MDR or the performance evaluation under the IVDR. In contrast, “intended use” specifies, in practical terms, how the product is to be used appropriately within this framework. It includes, in particular, information on the user group, application steps, application environment, handling, restrictions, warnings, contraindications, and, where applicable, transport, storage, Inspection, maintenance, and reprocessing. This information is typically found in the instructions for use, the label, and other accompanying documentation.

In practical terms, this means that the intended purpose primarily answers the question of what a product is intended for, while the intended use additionally describes how, by whom, under what conditions, and within what limits a product should be used. Since both levels must be consistent, contradictions between the intended purpose, instructions for use, technical documentation, clinical evaluation or performance evaluation, and promotional claims can lead to discrepancies in the conformity assessment process.
 

Qualification: Does the product fall under the MDR or the IVDR?

Qualification determines whether a product is a medical device as defined in Article 2(1) of the MDR or an in vitro diagnostic medical device as defined in Article 2(2) of the IVDR. IVDs are medical devices intended for the in vitro examination of specimens derived from the human body. Products with a medical purpose whose primary function is not the in vitro examination of such samples fall under the MDR.

Several distinctions are relevant in practice:

• Drugs: The decisive factor is the intended primary effect. If this effect is achieved pharmacologically, immunologically, or metabolically, the product is generally not considered a medical device.
• Wellness, fitness, and lifestyle products: Without a medical purpose as defined, the product does not qualify as a medical device. The distinction is based on the intended purpose, not on the technology.
• Accessories: Accessories are classified independently and are not automatically assigned to the class of the main product.
• Annex XVI of the MDR: Certain product groups without an intended medical purpose, such as certain aesthetic products, are nevertheless subject to the MDR.
• Software: MDCG 2019-11 Rev. 1 applies supplementarily to the qualification and classification of MDSW (Medical Device Software). The decisive factor is whether the software performs its own medical function or merely stores, transmits, or displays data.

In cases of doubt, structured procedures for clarification are available. In Germany, the BfArM conducts a review of the delineation and classification of a product upon receipt of an application (Section 6 MPDG). At the European level, the Manual on Borderline and Classification documents coordinated assessments of borderline cases.
 

Classification according to the MDR: Annex VIII

Under Article 51 of the MDR, the manufacturer classifies its product as Class I, IIa, IIb, or III. This classification is based on the 22 rules in Annex VIII of the MDR. The rules are based on duration of use, invasiveness, physical contact, active or non-active function, and specific product characteristics. If multiple rules apply, the rule that results in the higher class applies. Explanations and examples are provided in MDCG 2021-24 Rev. 1.

Rule 11 applies to software with its own intended medical purpose. Put simply, software that provides information for diagnostic or therapeutic decisions is generally classified as Class IIa. The class increases to IIb or III if the decisions in question could lead to a serious or irreversible deterioration in health. The wording of the intended purpose directly determines the class in this case.

In the event of a disagreement between the manufacturer and the Notified Body regarding classification, the competent authority of the member state shall make the decision in accordance with Article 51(2) of the MDR.
 

Classification under the IVDR: Annex VIII

For IVDs, Article 47 of the IVDR applies in conjunction with Annex VIII of the IVDR. Annex VIII of the IVDR contains implementing provisions and seven classification rules that result in the classes A through D. Class D is the highest class. Explanatory notes are provided in MDCG 2020-16, as amended.

The difference from the previous IVD Directive (IVDD) is structural. The IVDD relied on product lists, while the IVDR employs a risk-based regulatory system that combines individual risk and public health risk. Rule 6 serves as a catch-all provision and results in Class B. Therefore, essentially only non-sterile Class A products can be marketed without the involvement of a Notified Body.

Additional requirements apply to Class D. These include, among other things, the involvement of EU reference laboratories and, where available, the application of Common Specifications. Class C is designated for companion diagnostics, in conjunction with a Consultation procedure with the competent drug regulatory authority or the EMA.
 

Implications for conformity assessment, evidence, and timeline

The class determines the conformity assessment procedure and thus constitutes the bulk of the project effort. Four points are particularly relevant for planning in this regard.

1. Involvement of a Notified Body. Starting with Class Im, Ir, Is (MDR) or Class A (sterile) (IVDR), a Notified Body must be involved. Capacity and processing time must be factored into the planning accordingly.
2. Evidence Requirements. The scope of the clinical evaluation under Article 61 and Annex XIV of the MDR increases with the class. For IVDs, the same applies to the performance evaluation under Article 56 and Annex XIII of the IVDR, which includes the components of scientific validity, analytical performance, and clinical performance.
3. Post-market obligations. The class and product type determine, among other things, whether a Periodic Safety Update Report (PSUR) must be prepared in accordance with Article 86 of the MDR or Article 81 of the IVDR - and at what frequency.
4. Changes. An expanded indication, an additional user group, or a modified presentation of results may change the class. Changes to the intended purpose should therefore be treated and reviewed as changes to the Product and trigger re-reviews.
    

Impact on product scope and reimbursement pathway

The intended purpose defines the regulatory scope of the product. It specifies which functions and modules are part of the medical device or IVD and which fall outside the regulated product. This gives rise to specific requirements for system architecture, interfaces, user group, usage environment, and technical documentation. If this delineation is made late in the process, rework on architecture, Risk management, Verification/Validation, and documentation is often required.

Equally relevant is the reimbursement pathway. Conformity assessment establishes marketability but does not guarantee reimbursement. Reimbursement systems, however, are tied to characteristics defined in the intended purpose:

• Digital Health Applications (DiGA): Eligibility under Section 33a of the German Social Code, Book V (SGB V) requires that the primary function be based primarily on digital technologies and that a specific healthcare purpose be pursued. This covers medical devices in risk classes I, IIa, and IIb. Class IIb is subject to more stringent documentation requirements. IVD software is not covered by the Scope.
• List of Medical Aids (Hilfsmittelverzeichnis), New Examination and Treatment Methods (NUB) procedures, diagnosis-related groups (DRGs), and the Uniform Value Scale (EBM): The context of application, user group, and healthcare situation - which stem from the intended purpose - are decisive here.
• EU Health Technology Assessment (HTA) / Joint clinical Assessment (JCA): For certain high-risk products, a joint clinical evaluation at the EU level may be required, with the specific questions depending on the indication and the comparator therapy.

The reimbursement pathway should not be considered only after the conformity assessment has been completed. It is advisable to test, already during the formulation of the intended purpose, whether the targeted reimbursement aligns with the risk class, indication, target population, user group, and healthcare context. In addition, the evidence requirements from the regulatory conformity assessment and reimbursement procedures should be reconciled at an early stage. Ideally, any study design should be structured to cover both the requirements for safety and performance - or clinical evaluation - and the benefits and healthcare outcomes relevant to reimbursement. Discrepancies between the regulatory intended purpose and the intended purpose for reimbursement should be documented and strategically justified.
 

Practical approach

• Establish the intended purpose in writing before the architecture, study design, and marketing claims are finalized.
• Document the qualification, i.e., assignment to the MDR or IVDR, and differentiation from drugs, accessories, Annex XVI, and the unregulated area, providing justification in each case.
• Justify the classification based on regulations; list all reviewed provisions of Annex VIII - not just the applicable ones - and cite the relevant references in the guidance documents.
• Regularly perform testing on the intended purpose, label, instructions for use, and marketing materials against one another.
• Involve the intended reimbursement pathway early on and treat changes to the intended purpose as product changes within the change management process.

FAQ

Who determines the intended purpose?

The manufacturer. The manufacturer is also responsible for qualification and classification. Notified Bodies and regulatory authorities may conduct testing as needed.

Can a more narrowly defined intended purpose lower the risk class?

Yes. However, the intended purpose must cover the actual use. A restriction that deviates from the intended use is not tenable and may be challenged during market surveillance.

What happens in case of a disagreement regarding classification?

In the event of a disagreement between the manufacturer and the Notified Body, the competent authority decides in accordance with Art. 51(2) of the MDR. In Germany, an application may also be filed with the BfArM pursuant to § 6 of the MPDG.

How is software with multiple functions treated?

Modules with their own medical function are considered separately. According to MDCG 2019-11, it should be determined which modules fall within the regulated scope and how they are distinguished from one another.

Does the intended purpose need to be updated in the event of changes?

Yes. New indications, user groups, or functions can alter the qualification and classification. Such changes must be reviewed and, if necessary, coordinated with the Notified Body.
 

Conclusion

Intended purpose, qualification, and classification are the first three decisions in a project and significantly determine its subsequent course. They determine the conformity assessment procedures, evidence requirements, timeline, product design, and realistic reimbursement pathways. If they are determined early on, in writing, and with proper justification, subsequent corrections to documentation, architecture, and study planning can largely be avoided.

If you would like to determine the regulatory status of your product or have an existing classification reviewed, we can assist you. Schedule a no-obligation initial consultation.

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This article is intended solely for general informational purposes and does not constitute legal advice. All content was reviewed by experts prior to publication and is regularly checked for currency, completeness, and accuracy. Despite careful preparation and quality control, errors, omissions, or changes in the legal situation that have occurred in the meantime cannot be ruled out.