In the complex world of medical device manufacturing, claims management plays an important role in ensuring customer satisfaction and compliance. A critical component of this process is creating and managing the Instructions for Use (IFU), which provides vital information on the safe and effective use of medical devices. However, certain questions frequently arise when it comes to developing these IFUs, particularly with regard to publishing in a digital format, meeting the “intended purpose” requirement, ensuring usability, and determining the need for translation. In this article, we address these questions and try to provide insights and practical guidance on them for medical device manufacturers targeting the European market.
Claims Management – what is that?
Within the meaning of the MDR / IVDR a „claim“ is an assertion made by the medical device manufacturer regarding his medical device. It is directly linked to the clinical performance of the same. Any claim made by the manufacturer needs to be proven and shall not contradict to the stipulated intended purpose, device safety and performance as well as clinical benefit. When talking about claims management, the intended purpose of the medical device should be understood as the central, leading claim. Any other claim made – e.g. within marketing material, during training sessions, or when setting up the technical specifications – must range within this very first and central “claim” – the intended purpose. And where do I record this intended purpose claim? It should be recorded in a clear manner in the technical documentation as specified in the Annex II of both the MDR and IVDR under section 1.1. And based on this record it is also a core part of the instructions for use. And any other claim to be made within the marketing material, on the website or any other product related document or statement shall be listed as part of the technical specifications also under section 1.1 and must be proven within chapter 6.1 and 6.2 through out the technical documentation requirements of Annex II – most probably as part of the clinical evidence. So Claims Management requires a manufacturer to define his products claims within the technical documentation, to prove that each claim is true and to market the product only within the claims made and where sufficient evidence can be provided.
Advertisement and claims
When placing a product on the market, it is a natural thing to promote the same. This is also true for medical devices. In general promotion shall never be misleading or untrue. For medical devices of any kind, requirements are even more specific. Article 7 of both the MDR and the IVDR specifies which way is not acceptable when it comes to claims. Within the instructions for use or on the outer appearance of a medical device most manufacturers do not tend to provide misleading information. However, as soon as the marketing strategy including any marketing material or presentation of the product on the website is being established, sticking to the fixed intended purpose seems to be a difficult challenge for some manufacturers. For instance some may be tempted to state “quicker than the competitor” or “less painful than before” – two claims that must be treated very carefully to not fall under Article 7. In order to prevent that any claimwould need to be proven using relevant data the manufacturer has established within his technical documentation including sufficient clinical evidence as identified, appraised and analyzed in the Clinical Evaluation of the medical device
Little note: the more innovative the product is – the longer it takes to establish all relevant data. So either you have a short time to market with probably little innovation or you have a real innovation to claim resulting in a longer time to market.
Infringement of both Article 7 and additional national regulations (such as the German Heilmittelwerbegesetz) may not only lead to sales problems but also to fines or even more drastic penalties.
How do I deal with the “intended use” in the IFU?
Defining and accurately representing a medical device’s “intended use” is a fundamental and mandatory aspect of the IFU. The intended use describes the device’s purpose, target population, and specific indications for use. Medical device manufacturers must diligently evaluate and document the intended use, ensuring clarity and alignment with the device’s design and capabilities. Close collaboration between the regulatory, engineering, and marketing teams is essential. Additionally, engaging with healthcare professionals and conducting user testing can provide valuable insights into optimizing the language, layout, and instructions within the IFU to ensure users fully understand the device’s intended use.
Manufacturers should ensure that the intended purpose is clear, accurate, and aligned with regulatory requirements and clinical evidence.
How can the IFU be user-friendly
User-friendliness is paramount when it comes to the IFU. Users, including healthcare professionals and patients, rely on clear instructions to navigate the safe and effective use of medical devices. To enhance user-friendliness, manufacturers should employ plain language, employing clear and concise instructions without technical jargon or ambiguity. Utilizing visual aids, such as diagrams, illustrations, and step-by-step instructions, can significantly enhance comprehension. These are requirements included in the Medical Device Regulation (23.2). In addition, incorporating end-user feedback during the development process can help identify areas for improvement and ensure that the IFU is accessible and usable by its target audience. Other important requirements on usability can be found in the standards EN IEC/IEEE 82079 and EN 62366. And in case a claim made is directly linked to the steps to be taken by the user, validation within usability testing is a MUST.
Do I need to translate the IFU?
The short answer is yes. According to European legislation, it is generally required to translate the IFU of medical devices into the official languages of the countries where the devices are intended to be marketed and used. But translating the IFU is also crucial for ensuring accurate communication and user safety – including any stated claim and any possibly underlying interpretation of the same within the specific language. Therefore, manufacturers should always be aware of linguistic and cultural nuances, and use professional translation services specializing in medical and technical documentation. It’s worth noting that the exact language requirements may vary slightly between EU Member States, so it’s important to consult the specific regulations and guidelines of each country where you plan to market your medical device. Finally, collaborating with in-country experts can assist in evaluating and adapting the content, ensuring that it complies with local regulations and meets the linguistic needs of the end users.
Can I publish the IFU in a digital format?
This remains a common question, and not surprisingly. The advent of digital technology has transformed many industries, including healthcare. Consequently, medical device manufacturers have begun exploring the possibility of publishing IFUs in a digital format. But while digital IFUs offer numerous benefits, such as improved accessibility, cost reduction, searchability, and flexibility, manufacturers must navigate regulatory requirements and ensure compliance. These requirements are scattered across various European legislation sources, making it sometimes challenging to locate them. One we can’t miss is EU Regulation 2021/2226 regarding electronic instructions for the use of medical devices. This regulation expands on the 2017/745 regulation on medical devices and, among other things, describes what kind of devices are eligible for a digital IFU, which elements should be covered by a documented risk assessment, and when the IFU should also be on a website.
Support for Manufacturers
Claim management and IFU development are closely linked, and it is of utmost importance for medical device manufacturers to address the key questions surrounding the IFU. By taking a comprehensive approach that takes into account regulatory guidelines, user feedback, and industry best practices, manufacturers can empower users to use medical devices safely and effectively. Specialized companies such as seleon and INSTRKTIV help manufacturers reduce their risks and improve their market position with advice and providing support.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
