Medical software must be registered in the UK and/or EU if it qualifies as a medical device based on its intended purpose, not just on what features it has.
Under UK and EU regulations, software is considered a medical device when it is intended to be used for:
Diagnosis
Prevention
Monitoring
Prediction
Prognosis
Treatment or alleviation of disease or injury
If your software performs any of the above, it is likely regulated and must be registered before being placed on the market.
How regulators decide if your software needs registration
Regulators do not look at the technology alone. They assess:
Intended use
What you claim the software does (website copy, app store descriptions, marketing material, user guides).Clinical impact
Whether the software influences medical decisions, patient care, or treatment pathways.Risk to the patient
What could happen if the software gives incorrect output or fails.
Examples of medical software that typically requires registration
Even low-risk software may still need registration if it meets the medical device definition.
Common Class I medical software (low risk)
These usually require registration but not a Notified Body:
Wellness and lifestyle tracking apps with medical context
Symptom logging or patient-reported outcome tools
General health information apps (with medical intent)
Non-diagnostic monitoring apps
Telehealth and video consultation platforms
Appointment and patient management systems
Medication reminder apps
Rehabilitation or exercise guidance apps
Software that records, stores, or manages medical data
Basic medical image viewers (without diagnostic interpretation)
Software that may fall into higher classes (IIa, IIb, or III)
Your software is likely higher risk if it:
Performs diagnostic analysis
Provides treatment recommendations
Uses AI or algorithms to assess health risks
Supports or influences clinical decisions
Analyses medical images or physiological data
These products require additional regulatory steps, including Notified Body involvement.
Software that usually does NOT require medical device registration
Software is generally not regulated if it:
Is purely administrative or operational
Provides only general wellness or lifestyle advice
Tracks data without medical interpretation
Does not claim to diagnose, treat, or monitor medical conditions
⚠️ Important:
Simply calling an app “wellness” does not exempt it if the functionality or claims suggest medical use.
Does Class I software still need registration?
Yes.
Most Class I medical software still requires:
Technical documentation
Risk management records
Declaration of Conformity
Registration with the relevant authority (UK or EU)
Class I usually allows self-certification, meaning a Notified Body is not required in most cases.
UK and EU registration differences
If you sell in both regions:
EU: Must comply with EU MDR (2017/745) and appoint an EU Authorised Representative if you are outside the EU
UK: Must comply with UK MDR 2002 and appoint a UK Responsible Person if you are outside the UK
Registration is separate for each market.
Why correct classification matters
Incorrect classification or missing registration can lead to:
App store or marketplace takedowns
Amazon listing suspension
Regulatory enforcement actions
Fines or forced market withdrawal
Increased legal liability
How Euverify helps
Euverify helps you:
Determine whether your software is regulated
Classify your software correctly (Class I, IIa, IIb, III)
Prepare required documentation
Register your software in the UK and EU
Act as EU Authorised Representative or UK Responsible Person