Claims and their substantiation
The claims made by a manufacturer regarding the intended use, safety, and performance of their medical device or IVD medical device, both in their form and content, indubitably play an important role toward the commercial success of their product. It is therefore in the manufacturer’s interest to formulate the most appealing claims possible on the device. This can in certain cases lead to the communication of exaggerated or ambiguous claims on the device, particularly in, but not limited to, promotional material.
It is however imperative for manufacturers to have a clear understanding of what they are allowed or have the obligation to communicate to the user or patient regarding the intended purpose, safety, and performance of their medical devices. MDR/IVDR Article 7 states in essence that device manufacturers may not communicate any claim on the device which is not adequately supported by objective data. In this context, manufacturers should early in their device development stages define plans and methods in order to capture the safety and performance data necessary to substantiate any claim they intend to make on their devices. This Tech Letter will discuss Article 7 and its implications in terms of the safety and performance data required to substantiate a given claim.
With the introduction of Article 7 “Claims”, the MDR/IVDR reinforces the requirements for supporting evidence for any claim made by the manufacturer regarding the intended purpose, safety, and performance of their device, compared to the MDD/IVDD. MDR/IVDR Article 7 states the following:
“In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
(a) ascribing (i.e. attributing) functions and properties to the device which the device does not have;
(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.”
Importantly, Article 7 applies to any claim made in the form of text, names, trademarks, pictures and figurative or other signs. It is also specified to cover claims made in the information provided with the device by the manufacturer (labeling and instructions for use), in the technical documentation demonstrating conformity with the GSPRs of MDR/IVDR Annex I for the placing on the market or putting into service of the device, but also in advertisements. Thus, all claims must be substantiated, regardless of their form or the media or support they were communicated on. This also comprises electronic media, such as websites or social media.
Different types of claims may require to be substantiated with different kinds of data.
Different types of claims may require to be substantiated with different kinds of data. For instance, technical performance claims (e.g. accuracy of measurement in a device with a measuring function) must be supported by appropriate verification and validation testing data, usability claims (e.g. ease of use of the device by a lay user in a home environment) must be substantiated by data provided from adequate usability engineering formative and summative studies, and, perhaps most importantly, clinical performance claims (e.g. the ability to diagnose or treat a condition or pathology) require substantiation by data from clinical evaluation activities.
MDR Annex XIV Part 2 stipulates in that “the clinical evaluation shall be thorough and objective, and take into account both favourable and unfavourable data. Its depth and extent shall be proportionate and appropriate to the nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer's claims in respect of the device.”. Thus, any claims made by the manufacturer regarding the intended use, safety, and clinical performance of a device must be substantiated with clinical evidence presented in the Clinical Evaluation Report, compiled in accordance with the requirements of MDR Annex XIV.
Moreover, the manufacturer has the obligation to ensure that all “likely” risks associated with the device are communicated to the user or patient, in the light of the user’s technical knowledge, experience, education, and training on the device under its intended use. Furthermore, any residual risks associated with the use of the device must be communicated to the user in the form of limitations, contra-indications, precautions, or warnings in the informative material provided by the manufacturer.
The claims the manufacturer intends to make on the device should be formulated early on in the design and development process, alongside defining the user requirements for the future device. Indeed, for the claims to be appealing, they should align with specific and if possible unmet user needs. Thus, at this stage, the potential claims are often mostly shaped by marketing considerations.
The different claims the manufacturer would ideally like to make about the device must then undergo a reality check
The different claims the manufacturer would ideally like to make about the device must then undergo a reality check to determine which claims can be substantiated by existing literature, and which would require further verification and validation testing, usability studies, pre-clinical studies or clinical investigations in order to support them. Depending on the extent, notably in terms of costs and duration, of the further activities required, the claims are typically reconsidered, modified, and in certain cases abandoned because they will either be impossible or require a disproportionate effort to substantiate. The claims the manufacturer intends to make will therefore be modulated by the different activities required to substantiate them, and vice-versa.
Defining the claims is therefore an iterative process, implying close interaction between the marketing, engineering, and clinical teams
Defining the claims is therefore an iterative process, implying close interaction between the marketing, engineering, and clinical teams in order to define claims that are acceptable from the viewpoints of all parties concerned. These claims will be determinant in establishing the final verification and validation, usability engineering, and clinical evaluation plans for the device. The claims the manufacturer intends or hopes to make should also be carefully considered while designing the device’s post-market clinical follow-up (PMCF) plan as in certain conditions the data obtained in PMCF studies may be used to further substantiate the claims made by the manufacturer.
Whether you are a start-up or a well-established medical device manufacturer, Medidee will assist you in the planning and execution of your verification and validation, usability engineering, and clinical evaluation activities required to substantiate the claims that will be made for your device. Contact us at www.medidee.com/contacts/.
Article co-written by Jerome Randall and Mads Br?uner Madsen, with the participation of Peter Siejacks.