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In my experience working with early-stage medtech companies, I often see uncertainty around whether a device should be classified as Class I or Class IIa under the MDR. Many teams aim for a Class I designation to minimise cost and regulatory burden but ultimately find themselves slipping into Class IIa territory. From your perspective as a regulatory expert, what are the key indicators that clearly distinguish Class I from Class IIa classification, and what are the most common pitfalls companies make when trying to justify a lower classification?
A similar challenge I see in the sector is around distinguishing wellbeing products from regulated medical devices. Many companies aim to position themselves in the wellbeing space to avoid the regulatory burden, but their marketing or functional claims can easily push them into “medical” territory. From your experience, where does the real line lie between wellbeing and medical under the MDR, and what kinds of claims or design features most often cause companies to inadvertently cross that line?
Great questions Benjamin! I’m going to answer both in one reply as the answer is similar to both questions. These are two of the most common areas of confusion I see with early-stage MedTech teams and both ultimately come down to intended purpose and claims.
The real line between a wellbeing product and a medical device is drawn when medical functionality is claimed. A product is a medical device if it’s intended to diagnose, monitor, treat, alleviate, or compensate for a disease, injury, or disability, or to modify an anatomical or physiological process. It’s not the technology itself but the intended use and associated claims that determine this. A fitness tracker marketed for general wellness “supporting an active lifestyle” is not a medical device, but one that claims to “detect cardiac arrhythmias” or intended for use in monitoring patients in a hospital almost certainly is. The MHRA has a good guidance document related to software that is insightful on this topic. Once medical functionality is claimed, medical device regulations apply, and classification then depends on which rules in are triggered in applicable regulations taking into account the intended use, duration, invasiveness, and degree of interaction with the body or data.
Class I devices are generally non-invasive or passive, or have transient contact and no direct physiological effect. Once a device actively monitors a physiological process, delivers or withdraws energy, fluids, or substances, or processes information used for diagnosis or therapy, it usually falls into Class IIa. Many devices, particularly active ones and software under Rule 11, are up-classified under the MDR compared with the MDD, where rules were less prescriptive. This can lead to differences in classification and different regulatory pathways being followed.
Each classification rule must be reviewed objectively against the intended use, and classification is determined by the applicable rules, not business preference. The only time the classification (or regulatory applicability) changes is when the intended use or claims change, which is why companies must have robust change management processes to evaluate how modifications to claims, features, or target populations affect classification. In the EU, MDCG 2021-24 provide lots of examples of devices for each classification rule which is a helpful guide.
Some companies use classification strategically, starting with a lower-class device and limited claims to establish market entry and generate data, while planning for future submissions that expand functionality and claims. This can be a sound approach if managed transparently and with forward regulatory planning. The disparity between the UK and EU regulations can also be used strategically where a device is lower-class according to UK regulations which can lead to easier market access, whilst addressing more stringent EU requirements in parallel.
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A question from a company I am working with: Can we design our clinical evidence to satisfy both regulatory approval and NHS adoption/NICE evaluation simultaneously
Yes, and in fact, designing clinical evidence strategies that satisfy both regulatory approval and NHS/NICE requirements is not only possible but increasingly important.
The key is to align the evidence strategy early so that your clinical development plan supports both regulatory conformity assessment (demonstrating safety, performance, and clinical benefit under the regulatory frameworks) and health technology evaluation (demonstrating comparative clinical and economic value for NHS adoption). While regulators and NICE have different remits, one focused on safety and performance, the other on clinical effectiveness and cost-effectiveness, both rely on high-quality, clinically relevant data.
The optimal approach is to build a single, integrated clinical evidence plan that maps study endpoints to both sets of requirements. For example, pivotal studies designed for regulatory compliance should include patient-relevant outcomes, comparators, and resource utilisation metrics that feed into health economic models. NICE and the NHS also place emphasis on real-world evidence, which can complement pre-market data and strengthen both regulatory and reimbursement dossiers.
It’s important to engage early with all stakeholders to confirm that your study design, endpoints, and data collection methods meet the expectations of both audiences. Done well, this integrated approach can save significant time and cost, avoiding duplication while improving the chances of both market access and adoption. To achieve this, selecting partners with appropriate expertise in each area that can work together is critical.
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