HOW TO BUILD AN INTENDED PURPOSE FOR MDR

Introduction

MDR Article 2.12 defines “intended purpose” as: “the use for which a device is intended”. That statement is quite circular for a definition. While the remainder of Article 2.12 emphasizes the need of consistency between information material, clinical data and intended purpose, it still does not provide much help when it comes to building an intended purpose for CE-certification. However, there is no reason to despair. First, you probably have more experience with intended purposes than you think. The pharmaceutical industry has been drafting intended uses for decades. When you buy a medicine, you will find a pamphlet explaining what the medication is for, who should take it, when to take it, and so on. This is the intended use of the medication. While there are differences between the intended uses of medicinal products and those of medical devices, reviewing this information can give you an idea (and also inspiration) of what an intended purpose might look like. Furthermore, in this paper, we provide a clear methodology for defining the intended purpose of medical devices, along with examples and best practices. Before we dive into the methodology, let’s answer a few we are frequently asked.

2 The structure of the intended purpose

The MDR does not explicitely specify a structure of the intended purpose. However,

the MDCG points to the section of the MDR that they consider a specification of the content of intended purpose. Specifically, MDCG 2022-9 points to MDR Annex II, Part 1.1(c) as the requirements on the content of the intended purpose. This content includes “the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, con- traindications, warnings”. We can find confirmation of the MDCG approach in another part of the MDR, specifically Annex I, Part 23.4(b). This MDR section specifies that the IFU should include“the device’s intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate.” This structure is reminiscent of that specified in Annex II, Part 1.1(c). All-in-all, both MDR sections, highlight a similar structure, as follows:

1. Indication(s)

2. Target population(s)

3. Contraindications and warnings

4. Intended user(s)

In this document, we propose a slightly modified structure for the intended purpose with

two additional points:

1. Generic device group

2. Indication(s)

3. Target population(s)

4. Contraindications and warnings

5. Intended user(s)

6. Relevant safety and performance information

In the remaining of the document, we will analyze each element separately.

3 Generic device group

MDR Article 2.7 defines generic device group “a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics”. The regulation does not explicitly require the inclusion of the device group in the intended purpose. However, if the medical literature specifies standardized nomenclature to describe your device group, it is useful to provide this information at the start of the intended purpose. Consider an example. Devices that use UVA or UVB light to treat skin conditions are commonly referred to in the medical literature as “phototherapy devices”. Using this terminology ensures that users immediately understand the type of device being described. The intended purpose of such a device can thus begin with this information: