Whose Claim Is It Anyway?

Intended Use and Clinical Claims under the New EU Regulations

“My partner claims that vacuum cleaners are much better for cleaning floors than a brush. Personally, I think that’s a sweeping generalisation …”Indeed.   A rather less sweeping generalisation, however, is that the core function of the clinical evaluation, risk assessment and post market surveillance of a medical device or IVD – is supporting that device’s claims! But what exactly are claims, how should manufacturers develop and define them, and what aspects of the device’s technical and publicly available documentation are required to support them under the MDR and IVDR?

A device claim can be defined as any statement regarding its properties or function. Under this definition, the foundational claim of any device is its intended use, confusingly also referred to as its intended purpose. This is defined in Articles 2 of the MDR and IVDR as “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”. Thus, your device’s intended use is what you claim it’s meant to do in all and any formal information you provide to its intended users.

Articles 7 of the MDR and IVDR explicitly prohibit misinformation of any kind for device claims, such as “ascribing functions and properties to the device which the device does not have” and “suggesting uses for the device other than those stated to form part of the intended purpose”. It is therefore vital for manufacturers of new devices to strictly define their intended use very early on in the device development process, as it informs virtually every other downstream regulatory decision. For manufacturers of established devices, who are transitioning to the new Regulations, a complete review and gap analysis of your device’s labels, IFU and marketing materials is essential to ensure none of your publicly available information is in violation of Article 7 of either Regulation. Of note, claims are not just limited to statements, but cover any form of “text, names, trademarks, pictures and figurative or other signs” – for instance, a graphic-based advertisement for one your devices on the packaging of another, could easily create confusion; especially if the intended use of these devices differ.

Beyond intended use, every medical device or IVD will also have clinical claims, which are statements regarding the device’s performance and safety. These must be supported by your clinical evaluation report (CER), since Annex XIV of the MDR states that a CER’s scope is determined according to the “nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer’s claims”. The data sets that are  systematically collected, analysed and presented in your CER demonstrates the compliance of your clinical claims with the MDR or IVDR’s General Safety and Performance Requirements (GSPRs). Depending on the classification, established market status, or the novelty of your device, these data sets will come from clinical investigations on your own or an equivalent device, peer-reviewed scientific literature from your device’s medical field, pre-clinical evidence (such as animal or cadaver studies) and/or your post market surveillance activities. The latter may well identify unforeseen outcomes that could affect your clinical claims and require them, your CER and your risk assessment to be updated.

Any clinical claims you make in your labelling, instructions for use or marketing materials in any medium will be documented in your CER and rigorously assessed for their conformance to GSPRs 1 and 8. ( add Links to these Requirements? ).Such media include your company’s website(s), brochures, and advertisements, so it’s essential that all publicly available information is aligned with the intended use and clinical claims of your device, as defined and validated throughout your technical documentation.

If this sounds somewhat daunting, don’t worry – IMed’s clinical specialists are here to help. We can advise you on defining claims for new devices, or on assessing all and any claims you’ve already made, to ensure they’re fully validated in your CER, risk management, and other technical files. But please do book any CER updates in with us as soon as possible, so that we can work on your technical documentation and ensure your business stays compliant. You can contact IMed’s Medical writers on 01295 722800 or via email us at alison@imedconsultancy.com.