Knowing whether the MDR applies to your product is the first gate in your regulatory strategy. The scope is defined in Article 1 of Regulation (EU) 2017/745 and is broader than many founders expect. It covers not just traditional medical devices but also accessories, Annex XVI products with no medical purpose, and certain products with both medical and non-medical functions.
Here is exactly how to determine whether your product falls within MDR scope — and what to do if it does.
What Does Article 1 Say About MDR Scope?
Article 1(1) states that the MDR lays down rules concerning the placing on the market, making available on the market, and putting into service of medical devices for human use and accessories for such devices in the Union .
Article 1(2) extends the scope to include the groups of products without an intended medical purpose listed in Annex XVI .
The scope is defined by three conditions: 1. The product is a medical device (as defined in Article 2(1)) or an accessory to a medical device (Article 2(2)), OR falls into an Annex XVI product group 2. The product is intended for human use 3. The product is placed on the market, made available on the market, or put into service in the Union
All three must be met. A medical device intended only for animal use is not in scope. A medical device manufactured but never placed on the EU market is not in scope (though it may be subject to other jurisdictions' rules). A product that does not meet the medical device definition and is not in Annex XVI is not in scope.
What Products Are Explicitly Excluded from MDR Scope?
Article 1(6) lists specific exclusions :
- In vitro diagnostic medical devices — these fall under the IVDR (Regulation (EU) 2017/746), not the MDR
- Medicinal products — regulated under Directive 2001/83/EC
- Cosmetic products — regulated under Regulation (EC) No 1223/2009
- Food — regulated under food legislation
- Products derived from human blood, plasma, tissues, or cells (unless the device incorporates such substances as ancillary)
The boundaries between these categories can be blurry. A product that applies a substance to the skin could be a medical device, a cosmetic, or a medicinal product depending on its intended purpose and mechanism of action. The decision tree matters, and the European Commission has published guidance on borderline products .
How Do Accessories Fit In?
Article 2(2) defines an accessory to a medical device as an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical devices to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s) .
Accessories are regulated under the MDR in their own right. They must be classified independently from the device they accompany. This catches many startups by surprise — if you make an accessory for someone else's medical device, you are a manufacturer under the MDR with the full set of manufacturer obligations.
See MDR for Accessories: When Your Add-On Product Becomes a Regulated Device for a complete breakdown.
What About Software Scope?
Software is within MDR scope if it meets the medical device definition in Article 2(1). This means software intended for a medical purpose — diagnosis, monitoring, treatment, prediction, etc. — is a medical device.
Software that drives or influences a medical device is also potentially in scope, either as part of the device or as an accessory.
Software used for general purposes — practice management, appointment scheduling, health record storage without diagnostic functionality — is generally not in scope, even if used in a healthcare setting. The key question is always: does the software have a medical intended purpose?
MDCG 2019-11 provides a decision flow chart for determining whether software qualifies as a medical device . The essential test: does the software perform an action on data beyond storage, communication, or simple search? If it processes, analyzes, interprets, or transforms data for a medical purpose, it is likely in scope.
Geographic Scope: Where Does the MDR Apply?
The MDR applies in all EU member states directly. It also applies in the EEA countries (Iceland, Liechtenstein, Norway) through the EEA Agreement . Switzerland has separate bilateral agreements and its own medical device regulations, though it has historically aligned with EU requirements .
The MDR does not apply in the United Kingdom post-Brexit. The UK has its own regulatory framework — the UKCA marking system — though the practical implementation has seen multiple delays and changes. See MDR and Brexit: Selling Medical Devices in the UK as an EU Startup for the current state.
Turkey has historically aligned with EU medical device regulations and has been implementing its own version of the MDR .
What If Your Product Is on the Boundary?
Many products sit on the boundary between medical device and non-medical product. The MDR provides several mechanisms for resolving borderline cases:
Article 4(1): Where a product does not fall within the definitions of "medical device" or "accessory for a medical device," but the Commission determines it falls within the scope because it is similar to a medical device in terms of functionality and risk, the Commission may adopt implementing acts to determine whether the product falls under the MDR .
Member State decisions: National competent authorities can make determinations about whether a specific product falls under the MDR in their territory.
MDCG guidance: The MDCG publishes guidance on qualification and classification that helps resolve borderline questions.
In practice, if you are genuinely unsure whether your product falls under the MDR, the recommended path is:
- Conduct your own analysis against Article 2(1) — document your reasoning
- Consult MDCG guidance documents relevant to your product type
- If still unclear, submit a formal request to your national competent authority for a classification determination
- Consider seeking input from a Notified Body during an early-stage consultation
The worst approach is to assume you are not in scope without documenting why. If a competent authority later determines your product is a medical device, having no documented analysis looks like either ignorance or evasion — neither of which serves your startup well.
Scope Determination as Strategic Decision
Here is where the business perspective meets the regulatory reality. The MDR scope question is not just a legal exercise — it is a strategic decision that shapes your entire go-to-market plan.
If your product is in scope: you need a QMS, technical documentation, clinical evidence, and (likely) a Notified Body. Your timeline extends. Your costs increase. But you also gain the ability to make medical claims, which for many startups is the core value proposition.
If your product is out of scope: you can move faster and cheaper to market. But you cannot make medical claims. For some products, that trade-off makes sense — especially as a beachhead strategy where you launch with general wellness claims and later pursue medical device status. See The Beachhead Strategy: Launching as Wellness First, Then Transitioning to Medical Device.
The decision must be genuine. You cannot make medical claims without being in scope, and you cannot avoid scope while making medical claims. Attempting to have it both ways — marketing a product with medical-sounding claims while claiming it is not a medical device — is exactly the kind of regulatory arbitrage that competent authorities watch for.
At the end of the day, the scope question comes down to this: what claims do you want to make about your product? Your answer to that question determines whether the MDR applies to you.
Next: The Difference Between a Medical Device and a Wellness Product Under EU Law.