Muuza is now registered as medical device software
In 30 seconds
- Muuza’s software, model Muuza SaMD v2, was registered with Lithuania’s State Accreditation Service for Health Care Activities (VASPVT) on 16 June 2026.
- It is registered under the EU Medical Device Regulation 2017/745, the law for medical devices sold in the EU1.
- Registration means Muuza is built and run as a medical device, with the quality and safety duties that brings. It does not replace a clinician.
On 16 June 2026, Muuza’s software was registered as a medical device in Lithuania. It is a milestone we’ve worked towards from day one, because health tools that talk about your body should meet medical standards — not just app-store standards.
The registration at a glance
| Detail | Muuza |
|---|---|
| Device | Vaginal health symptom monitoring software |
| Model | Muuza SaMD v2 |
| Type | Software as a medical device (SaMD) |
| Regulation | EU Medical Device Regulation (EU) 2017/745 |
| Class | Class I |
| Registered with | State Accreditation Service for Health Care Activities (VASPVT), Ministry of Health of the Republic of Lithuania |
| Registration number | LT-CA01/MDD/1-00042/26 |
| Registration date | 16 June 2026 |
| Manufacturer | Muuza, MB (Palanga, Lithuania) |
What “software as a medical device” means
Most health apps are lifestyle products. A medical device is different: it has a medical purpose, and the law sets rules for how it is designed, tested, documented and monitored once people use it. When the software itself does that job, without being part of a physical device, it is called software as a medical device, or SaMD.
In the European Union, these rules are set by the Medical Device Regulation (EU) 2017/7451. It classifies devices by risk, from Class I (lowest) to Class III (highest). Software that gives information used for diagnostic decisions is usually placed in a higher class; other medical software falls into Class I1.
What it means for you
- Built to a standard. Muuza is designed and documented as a medical device, with a defined purpose and risk management.
- Monitored after launch. As a manufacturer, Muuza, MB has to watch how the software performs and act on problems.
- Clear about its purpose. Muuza is registered as symptom monitoring software. It helps you understand your symptoms and decide what to do next. See when to use Muuza and how AI supports women’s health.
Myth vs fact
Myth: A registered medical app can diagnose me.
Fact: Muuza gives a doctor-curated assessment and clear next steps. A diagnosis comes from a clinician, often with a test.
Myth: All health apps follow medical rules.
Fact: Most are not medical devices. Medical device software has to meet the EU Medical Device Regulation1.
Where to find the details
The registration details are shown at the bottom of every page on this website and on our contact page.
Try this
- When choosing a health app, check whether it is registered as a medical device and who the manufacturer is.
- Read how it handles your data. Intimate health data should never be sold.
When to see a doctor
- Whatever an app says, contact your GP, NHS 111 or a sexual health clinic if you have a fever, pelvic pain, bleeding after sex or between periods, or any symptoms in pregnancy.
Quick check: Which EU law sets the rules for medical device software like Muuza?
The Medical Device Regulation, Regulation (EU) 2017/7451.
References
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (Medical Device Regulation). eur-lex.europa.eu/eli/reg/2017/745/oj
This article is for general information and does not replace medical advice. If you are worried about your symptoms, contact your GP, a sexual health clinic, NHS 111 or, in pregnancy, your midwife.
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