Our Life Sciences Legal Forum offers a series of quarterly sessions focusing on hot topics within the life sciences sector. In a recent webinar, we explored the complexities of borderline products, focusing on categories that often raise challenging questions. This blog series delves into these issues, with a particular emphasis on medicinal devices and MedTech, medicines and ATMPs, food supplements, consumer products, and advertising.
Understanding Borderline Products
Borderline products are those that may fall into more than one product category. Determining their classification requires careful consideration of factors such as intended purpose, mode of action, and product claims. Understanding these nuances is crucial for regulatory compliance and cost-effective product development.
Focus on MedTech
In the first instalment of this blog series, we focus on MedTech, including medical devices and healthcare software.
We are currently seeing a rapid growth in the number and range of health and wellness-related apps, including software and AI as medical devices. Following the COVID-19 pandemic, a move towards telehealth and remote care accelerated the increase in activity in this area.
According to the IQVIA Institute Report Digital Health Trends 2024, the number of digital health apps stood at 337,000 at the end of 2024.
Challenges in Classification
Correctly classifying these products can be challenging. Distinguishing between general wellness apps or consumer products, such as ancestry testing, and those that fall within the scope of medical device legislation is vital for ensuring regulatory compliance and patient safety. Even minor changes to a product and its presentation can significantly impact its classification and, consequently, its regulatory status.
Legislation and Compliance
Medical device legislation covers traditional 'hard' medical devices like scalpels, syringes, and MRI scanners, as well as in vitro diagnostic products and health-related software. Products within the medical devices remit require an appropriate level of conformity assessment, leading to a CE or UKCA mark in the EU or UK markets. To qualify as a medical device, a product must be an "instrument, apparatus, appliance, software, material," etc., intended for a medical purpose and not acting through "pharmacological, immunological, or metabolic means."
Manufacturer Intention and Presentation
The manufacturer's intention is central to defining a medical device, making the product's presentation crucial. Regulators consider everything from packaging and instructions for use to marketing materials (including social media campaigns and websites) and advertising press releases.
Health App Space
We frequently encounter issues around borderline products in the health app space. For example, a fitness tracker that allows users to input exercise levels and food intake to calculate overall health goals is unlikely to be considered a medical device. In contrast, an app designed for diabetic users to collect food intake information for assessing insulin requirements would fall within the medical device category.
Beyond Product Classification
Beyond product classification, it may be necessary to consider whether a digital service constitutes a healthcare service, potentially engaging oversight by the Care Quality Commission.
In the second instalment of this series, we will focus on medicinal products and their borderlines with other product types.
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