IVDR: The intended purpose (for beginners & those experienced with IVDD)
And in the beginning, there was the intended purpose… and once this has materialised in the mind of the creator, the pathway to the completed IVD device can start. It provides the direction for the entire development project as without it, key decisions cannot be made. Even before it has been finalised, it’s important to dedicate a decent period of time to it. Failing to entirely think things through at this point may hinder the device classification, design & development, risk management processes as well as performance evaluation plans. Spending too little time may result in project inefficiencies, e.g. design change, additional or repetition of validation work.
As defined in the IVDR (2017/746), Article 2(12):
‘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 or as specified by the manufacturer in the performance evaluation;
Let’s look in more detail how the intended purpose impacts downstream processes and how it is referenced by different sections of the IVDR:
Classification of the device cannot be undertaken until the intended purpose is clear, how do we know this? Well, first rule of Annex VIII (Classification Rules) states; application of the classification rules shall be governed by the intended purpose of the devices. Without classification you don’t know the extent of the work ahead needed to fulfil compliance requirements. So again, I cannot stress enough, this is why it is so important that the intended purpose is defined right at the beginning.
Device Design and Risk Management
Your device needs to, as appropriate, meet the General Safety & Performance Requirements (GSPR), as specified in Annex I. ‘Intended Purpose’ is referenced throughout, specifying that requirements are met, ‘taking into account’ the intended purpose. They are all inter-linked with management of risk, for example: Devices shall be designed, manufactured and packaged in such a way that exposure of users or other persons to radiation (intended, unintended, stray or scattered) is reduced as far as possible and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for diagnostic purposes.
Performance Evaluation & Clinical Evidence
If we look at Article 56 of the IVDR, we can see how the intended purpose will impact the performance evaluation and collection of clinical evidence: The manufacturer shall specify and justify the level of the 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.
Developing & Presentation of the Intended Purpose Statement
So how best to construct your intended purpose? Essentially it shall be a brief statement which includes information concerning the intended use, the intended user, the patient population, and indications for use (including any contraindications). For any individual who is responsible for defining the intended purpose statement, my advice is the same, sense check draft statements against Annex II, paragraph c.
- c) the intended purpose of the device which may include information on: (i) what is to be detected and/or measured; (ii) its function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic; (iii) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate; (iv) whether it is automated or not; (v) whether it is qualitative, semi-quantitative or quantitative; (vi) the type of specimen(s) required; (vii) where applicable, the testing population; (viii) the intended user; (ix) in addition, for companion diagnostics, the relevant target population and the associated medicinal product(s).
It is highly likely that certain elements of your intended purpose (indications for use, patient population) will not be confirmed until the performance evaluation has been completed, but at the very least it is still important to begin in earnest with a suitable draft statement. This can always be amended later.
As specified in the General Safety & Performance Requirements (GSPR) of Annex I, chapter III, the intended purpose, as defined above, will need to be presented in the labelling information which accompanies the device, i.e. the instructions for use. Likewise, as per Annex II, the intended purpose must clearly presented with the technical documentation that is compiled for the device. In addition, as per Annex IV the statement will also be a feature of the declaration of conformity.
Important to note:
The Intended purpose is not a general description of product features or specifications. This information is to be included in other parts of the IFU and technical documentation file.
Legacy Devices & How IMed Can Help
For those with legacy devices the challenge then is to make an assessment of any gaps between the original Intended Use statement and product claims with the new requirements of the IVDR (described) above. Following this gap assessment, if further performance evaluation is required to substantiate claims then changes may be required.
To summarise, the intended purpose is where everything starts, it drives the direction of your device development. It is visible to everyone, end users, notified bodies, competent authorities. If there are any cracks, they will soon be found out. The old saying, it does exactly what it says on the tin. That’s it in a nutshell, that’s exactly what you want from your intended purpose.
Our experts have had many years of practice of preparing statements such as this so if you wish to tap into our knowledge base then please get in touch with IMed. We are more than happy to help or have a chat about your IVD queries. Call us now on 01295 724286 or email us at firstname.lastname@example.org.
IMed QA & IVDR Consultant