Stay within the law when testing for ADHD
Why CE-marked ADHD tests are a non-negotiable in UK clinics
Using a medical device without MHRA registration can lead to serious consequences for clinicians, including potential prosecution, professional misconduct investigations, and permanent reputational damage.
Devices that don’t meet regulatory standards can also be withdrawn from the market entirely, disrupting care pathways and putting patients at risk.
If you're using ADHD assessment tools that aren’t CE-marked or listed on the MHRA database, you're not just taking a clinical risk, you could be taking a legal one too.
The risks of using unregistered devices
Even though regulations primarily target manufacturers, clinicians can face serious consequences if something goes wrong. That includes:
- Professional misconduct investigations
- Civil claims for negligence
- Prescribing errors, especially concerning when 70% of ADHD patients are prescribed controlled medication
- Reputation damage, particularly for private clinics where trust is everything
The General Medical Council is clear: clinicians must act in the best interests of their patients. Using a device without proper clearance risks falling short of that standard.
IMPORTANT
It is illegal to market a medical device without the correct regulatory clearances. You can report concerns about breaches directly to the MHRA.
What to check before adding new ADHD technology
Here’s how to minimise clinical, legal, and reputational risk:
- Search the Medicines & Healthcare products Regulatory Agency’s (MHRA) database
Make sure any ADHD test is officially registered and listed. - Check for a CE marking or a UKCA mark
This is the manufacturer’s declaration that the device meets UK and EU safety and performance standards. - Follow MHRA guidance. Before using any new test, review:
- Training and support
- Data security
- Software compatibility
- Setup requirements
Why it matters for your patients
Many patients wait years before seeking an ADHD assessment. By the time they reach your clinic, they’re expecting clarity, not complexity.
CE-marked and registered tests help deliver:
- Greater diagnostic transparency
- Evidence-based support for your clinical judgement
- A defensible pathway for shared care
- Confidence, for you and your patients
QbCheck: Fully registered, CE-marked
QbCheck is:
- CE-marked
- Listed on the MHRA database
- FDA-cleared in the US
- Backed by extensive clinical research
Whether you’re running a private clinic or an NHS service, we’re here to support safe, objective, and efficient ADHD care.