When a client says "but Company X does this and they are not regulated," they are making a category error. They are confusing being on the market with being compliant. These are not the same thing. This module gives you the knowledge, the ethical framework, and the practical tools to handle that conversation correctly every time.
Common issues: Clients say “but X company does this and they're not regulated”. How should advisors respond?
Before discussing how to analyse a competitor or when to report them, you need a clear ethical framework. This is not optional.
Reporting a competitor to the MHRA can be both a legitimate patient safety act and a commercially motivated action. These are not mutually exclusive and that is exactly what makes this ethically complex.
A non-compliant product making dangerous clinical claims and deployed in NHS settings is a patient safety issue regardless of who identifies it. A clinician or regulatory advisor who becomes aware of a product that is actively harming or could harm patients and does nothing has arguably failed a professional duty.
Using the regulatory system primarily to eliminate a commercial competitor, even if there is a technically valid basis for the report, is ethically questionable and potentially damages your professional reputation if it becomes apparent that the primary motivation was commercial.
You are building a commercial practice in the same market you are advising in. If your client's competitor is non-compliant, you have both a professional interest in patient safety and a commercial interest in reducing competition for your client.
This conflict of interest must be acknowledged and managed.
Ask yourself honestly whether you would report this product if your client had no commercial interest in the outcome. If the answer is yes because the patient safety concern is clear and serious, report.
If the answer is no because the primary motivation is commercial, do not report. Document your reasoning either way.
Reporting a competitor on behalf of a client creates a paper trail connecting you to a commercial complaint. This can be reputationally damaging if the report is later seen as vexatious or commercially motivated.
Consider whether the report should come from your client directly rather than from you as their advisor.
When a client raises a competitor, resist the instinct to immediately validate their frustration. The most useful response is accurate, not sympathetic.
"The fact that a competitor is on the market does not mean they are compliant. MHRA's digital enforcement is currently reactive, not proactive.
Most DMHT companies operate in regulatory grey zones or outright non-compliance. That is a calculated risk some companies take.
You need to decide whether you want to take that risk."
"What matters for your company is not what your competitors are doing but what your regulatory position is. A competitor's non-compliance is not a reason for you to delay compliance.
If anything, their non-compliance is a risk to the market: if they cause a serious incident, the MHRA's response could affect procurement decisions across the entire DMHT sector."
Work through the seven steps below in order. Document each step before moving on — the documentation is what protects you whether or not you escalate.
Search for the company name and product name at the MHRA device registration portal. If the product is not registered and it is a SaMD, it is non-compliant with the basic requirement of UK MDR 2002.
Screenshot the search result and date it.
Screenshot any claims made. Note whether the UKCA mark is displayed and whether an Approved Body identification number is shown.
An Approved Body number is required for Class IIa and above: its absence on a product claiming to be Class IIa or above is a compliance indicator.
Capture the intended purpose from the App Store description and the product website separately. Note any discrepancies between the two.
Discrepancies between the App Store intended purpose and the website marketing are an indicator of inferred medical purpose under MHRA DMHT guidance Example 6.
Capture clinical claims made in the App Store, website, and social media. Note any claims that imply diagnosis, treatment, prevention of clinical conditions, or clinical equivalence to regulated interventions.
Record the date and URL for each screenshot.
UK Approved Body certificates are not always publicly searchable but some manufacturers publish them. BSI and TÜV Rheinland UK maintain certificate databases that are partially searchable.
Search the NICE evidence review database and the NHS Supply Chain for the product, along with any regional NHS or ICS app library (these are now run through ORCHA following the closure of the national NHS Apps Library in 2021). A product procured through NHS Supply Chain without MHRA registration is a serious compliance failure and a clear reportable scenario.
Record dates and screenshots in a structured file before making any decision about reporting. If you proceed to a report, the documentation supports it.
If you decide not to report, the documentation shows you considered it properly and protects you professionally if the product later causes harm.
uk/report-a-non-compliant-medical-device. Once a report is received, the MHRA assesses it using a risk-based system.
They prioritise reports involving clear patient safety risks, dangerous clinical claims, and deployment in clinical settings without registration. Borderline cases and commercially motivated reports are deprioritised.
The majority of MHRA compliance activities are initiated and resolved in writing. Most non-compliant DMHT companies that come to the MHRA's attention are given the opportunity to achieve compliance before enforcement action is taken, unless there is an immediate safety risk.
Immediate market withdrawal is rare.
Placing a non-compliant medical device on the UK market is a criminal offence under UK MDR 2002. The penalty on conviction is up to six months imprisonment, an unlimited fine, or both.
The unlimited fine replaced the previous cap of £5,000 per offence. In practice, prosecution is rare.
The more common outcome is a compliance notice and an opportunity to remediate.
The MHRA does not commit to specific response timelines for non-urgent reports. Reactive enforcement for DMHT products is slow in practice.
A report filed today may not result in action for months. This is relevant context for the client conversation: if a competitor is causing immediate patient harm, the MHRA can act quickly.
If the concern is regulatory non-compliance without immediate harm, the timeline is much longer and should not be presented to a client as a quick commercial remedy.
Report when all three of the following are true: the product is making dangerous clinical claims or is deployed in a clinical setting without registration; there is a clear and foreseeable patient safety risk, not a theoretical or remote one; and patient safety is the primary motivation for the report.
Document why. Record the competitor's product details, the non-compliance identified, and your reasoning for not escalating.
This protects you professionally if the product later causes harm and your earlier awareness becomes relevant.
uk/report-a-non-compliant-medical-device. Provide: product name, manufacturer name, App Store link or website URL, MHRA DORS registration status with screenshot, specific clinical claims with screenshot references and dates, deployment context (NHS or direct to consumer with evidence), and a clear description of the foreseeable patient safety risk.
The more specific and evidence-based the report, the more likely it is to receive prompt attention.
Form your own view first. Reveal the reference answer to compare reasoning.
Your client's competitor markets an app as a “digital therapeutic for depression” and is being procured by an NHS trust. They have no MHRA registration and no UKCA marking. Your client asks whether to report them. What do you advise?
A competitor product targets trans-diagnostic symptoms (worry, rumination, sleep) on its website without specifying any diagnosed condition, holds no MHRA registration, and is being used informally by clinicians at a single GP practice but has not been procured through NHS Supply Chain. The client has clinical claims documented from the website and wants to file a report immediately. What do you advise?
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Educational resource. Not formal regulatory or legal advice.
