Is your product a medical device?

A product is generally regulated as a medical device if its intended use is to diagnose, prevent, monitor, predict, treat, or alleviate a disease or condition, or to investigate, replace, or modify anatomy or a physiological process. Crucially, it is the claim that triggers regulation, not the technology. Consider two wearable devices with sensors that can measure blood pressure: one that tracks “stress and wellness trends” sits outside the medical device framework; one that claims to measure and detect hypertension almost certainly falls within it. The same product can be a medical device in one market but not in another, because the US, EU and UK draw the line between wellness and medical products differently. For example, a breast pump is a Class II device in the US (FDA), whereas it is not necessarily a medical device at all in the EU (MDR) or UK (MHRA), depending on the intended use. Working with a regulatory strategist early can help you set your course and decide which market to enter first.

Most frameworks use a risk-based classification system. Class I covers low-risk devices with minimal contact and consequence, such as a nipple shield. Class II covers moderate-risk devices, which may deliver energy to the body, be used for a longer period of time, be invasive, or have greater health or safety consequences if something goes wrong. An electrical muscle stimulator that treats female stress urinary incontinence is one example: it is Class II in the US and Class IIa under the EU MDR, which splits this middle tier into Class IIa and IIb. Class III is reserved for the highest-risk devices, typically those that sustain or support life, are implanted long-term, or where consequences could be severe. The higher the class, the more rigorous the clinical evidence and regulatory scrutiny required before you can market your device.

The frameworks share the same underlying principle, risk-based tiers, but apply it differently in practice. The EU MDR and UK MDR classify devices using explicit rules tied to factors like invasiveness, duration of body contact, whether the device delivers energy to the body, and whether it is used in a life-threatening condition. The FDA uses a product-code system with thousands of device types, each assigned a class and a corresponding regulatory pathway (510(k), De Novo, or PMA). A device that is Class II under FDA may be Class IIb under EU MDR. Global market strategies need to account for these differences from day one. Official sources: the EU Medical Device Regulation (EU) 2017/745 and the European Commission’s MDCG 2021-24 classification guidance; the MHRA’s guidance on medical device requirements in Great Britain; and the FDA’s Classify Your Medical Device page.

Yes. Great Britain (England, Scotland and Wales) currently accepts CE-marked medical devices and IVDs alongside the UK’s own UKCA mark. In October 2026, the UK government confirmed it will continue to recognise CE marking on a long-term basis, with no fixed end date for devices certified under the EU MDR and IVDR; the legislation to make this permanent still has to pass through Parliament. Devices approved under the older EU Medical Devices Directive (MDD) remain accepted only for a transitional period aligned with the EU’s own deadlines. Either way, a CE mark alone is not enough: you must register your device with the MHRA before placing it on the GB market, and manufacturers based outside the UK must appoint a UK Responsible Person. Northern Ireland follows different rules, closer to the EU’s.

Strategically, even if your first target market is the UK, it may make more sense to opt directly for a CE mark (with MHRA registration) instead of pursuing dual authorization pathways. If you need help figuring out whether this strategy is right for you, schedule a call - we'd love to help.

SaMD refers to software that carries out a function that is itself considered a medical device. Generally this does not refer to firmware that runs inside a hardware device, but to software whose primary function is to diagnose, monitor, or treat. A standalone app that analyses ECG data to flag arrhythmia is a SaMD. A dosage calculator that gives clinical decision support may be one too, depending on how it is described and how much it influences clinical decisions. SaMD (or medical device software, MDSW, depending on the geography) is one of the most actively evolving areas of medical device regulation, with specific guidance from FDA, IMDRF, and the EU. More and more, SaMD also relies on AI/ML, which may trigger additional testing, verification, and approval requirements under frameworks such as the EU AI Act and the FDA’s guidance on AI-enabled medical devices.

Not necessarily. It depends on the device class and whether a predicate device exists. Most Class II devices in the US require a 510(k) submission to demonstrate substantial equivalence to a legally marketed predicate. Class I devices are often exempt from premarket notification. Novel devices with no predicate may go through the De Novo pathway. Class III devices require a full Premarket Approval (PMA). Choosing the right pathway starts with understanding your device's classification and the regulatory history of similar products.

An Intended Use statement is a formal description of what your device is designed to do, for whom, and under what conditions. It is the regulatory anchor for your entire development programme. It determines your device class, your clinical evidence requirements, your labelling, and your post-market obligations. Getting it right early prevents costly repositioning later. Many founders write it too broadly, increasing evidence burden, or too narrowly, limiting their addressable market.

The typical journey involves: confirming whether your product is a medical device, determining its classification under your target markets’ frameworks, identifying the applicable regulatory pathway and submission type, building a Quality Management System (typically to ISO 13485), generating the required clinical and technical evidence, and making the relevant submission or registration. The timeline and cost vary enormously by class and market. Typically, a Class I EU MDR device takes 6 to 12 months, while a Class III PMA submission can take 3 to 7 years.

It can. AI/ML-based software, particularly where the model’s outputs directly influence clinical decisions, tends to attract higher scrutiny and may push a device into a higher risk class. In the EU, the AI Act is already in force and some of its obligations apply now; the requirements for AI-enabled medical devices that need a notified body assessment are currently scheduled to apply from August 2028. A separate European Commission proposal, still under negotiation, could shift more of that oversight into the MDR itself. In the US, the FDA has finalized guidance on predetermined change control plans for AI-enabled devices and is still developing its approach to evaluating AI, including how to measure real-world performance (FDA overview). This is a constant area of change: what was true a few months ago may not be true next week. If your device uses AI, declare it early, plan for additional evidence requirements, and make sure your regulatory strategist is tracking the latest updates. (Status as of November 2026.)