The intended purpose – or, what does your medical device do?
When deciding whether a product qualifies as a medical device, the intended purpose of the device is crucial. But what exactly is the intended purpose? What do manufacturers have to consider when defining the intended purpose? And how important is the exact wording?
It is not without reason that the correct formulation of the intended purposes of medical devices is crucial for their successful development and regulatory approval . In this post, we will discuss the intended purpose of medical devices with reference to the regulatory framework of the European Medical Device Regulation (EU) 2017/745. While the US FDA uses the term intended use, intended purpose and intended use are often used synonymously in the EU, and both terms are mentioned in the MDR.
What is the intended purpose of a medical device?
The MDR defines the intended purpose in Article 2(12) as follows:
‘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;
The manufacturer of a medical device is responsible for defining the intended purpose of the device, which has far-reaching consequences: the first is the basis of the decision whether or not a product is a medical device, in accordance with the definition of the regulation. The definition mentions documents such as label, instructions for use, and promotional or sales materials as well as the clinical evaluation.
But before any of those documents are produced, the intended purpose is a core part of one’s technical documentation, as Annex II. 1.1 of the MDR requires a general description of the device that includes the intended purpose. The intended purpose should be developed together with two other statements that are part of the technical documentation:
- a statement that includes the information about the intended patient population, medical conditions, indications, and contraindications,
- and the information on the principles of the operation of the device and its mode of action, scientifically demonstrated, if necessary.
The intended purpose describes the intended medical use—not the specific product features or specifications of an anticipated product—and has to be formulated in a clear, precise, and unambiguous way. It is important to highlight that the intended use has to be consistent throughout the entire technical documentation and in all future documents on the device.
When determining the intended purpose, consider to explicitly mention any limitations (i.e. what the medical device is not intended to be used for). It is essential to be as precise as possible, especially if the device could have a borderline medical purpose or if a different interpretation of the classification rules could lead to a different risk class. The wording of the intended purpose should be as clear and straightforward as possible to preclude different interpretations.
When should the intended purpose be defined and by whom?
The intended purpose of a device should be defined early in the medical device development process, as it is the basis for various significant decisions, and the wording will influence the subsequent steps. Not only is the intended purpose decisive for the qualification of a device as a medical device as such, it is also the basis for the application of the classification rules in Annex VIII to determine the risk class of the device, as outlined in Article 51. The classification then determines the conformity assessment route for the device, including the amount of clinical data required to demonstrate conformity with the relevant safety and performance requirements.
Even though documents such as labels, instructions for use as well as promotional materials will be created at a later point in time, these documents and the promotional strategy should be considered when defining the intended purpose. It is critical that the promotion and messaging of the product is consistent with the defined intended purpose.
Article 7 of the MDR prohibits misleading the user or patient with the device’s intended purpose by accrediting functions to the device or creating a false impression regarding treatment or diagnosis, which the device does not have, or not disclosing likely risks, and suggesting uses for the devices other than the uses included in the intended purpose.
The intended purpose should, therefore, be formulated by a medical, regulatory or quality professional (providing the crucial understanding of the regulatory and clinical consequences) and for the intended user group (either medical professional or patients) in the appropriate medical language.
How is the intended purpose linked to the clinical evaluation?
It is important to know that under MDR, there is a clear link between intended purpose and the clinical evaluation, which is not only mentioned in Article 2(12) but also in Article 61(1):
The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.
Manufacturers have to plan, to continuously conduct, and document a clinical evaluation for their device if used, as intended, to conform to the general safety and performance requirements set out in Annex I of the MDR. The description of the process in Part A of Annex XIV and Article 61 show that the intended purpose plays an important role for the clinical evaluation.
The intended purpose helps one identify the clinical data that is relevant to the device, and the depth and extent of the clinical evaluation depend on the intended purpose (as well as on the classification, risks of the device, and the manufacturer’s claims in respect of the device).
The characteristics of the device and its intended purpose are the basis on which a manufacturer justifies the level of clinical evidence that is required. When following the procedure for a clinical evaluation, a critical evaluation of the relevant scientific literature takes into account the intended purpose of the device.
MDR allows one to use clinical data sourced from clinical investigations, other studies, and reports published in peer-reviewed scientific literature on a device for which equivalence to the device in question can be demonstrated. If a manufacturer claims equivalence to an existing device, the intended purpose is one of the characteristics that has to be taken into account to demonstrate equivalence.
Does the MDR cover devices without an intended medical purpose?
This is a novelty introduced by the MDR, as Annex XVI contains a list of devices without an intended medical purpose, which are nonetheless covered by the regulation. Those devices are similar to medical devices in terms of functioning and risk profile, even though the manufacturers only claim non-medical purposes (for example, aesthetic ones).
Manufacturers have to demonstrate the conformity of such products to the MDR. Common specifications will be adopted for this purpose, covering at least the application of risk management and, where necessary, clinical evaluation regarding patient safety.
If you are looking for assistance in any step of the conformity assessment (including the wording of the intended use), here is how Decomplix can help.
Pictures: Bayurov Alexander, Vintage Tone/Shutterstock