About this software

PRODUCT IDENTIFICATION

Product name: ZIZ STI automated eHealth consultation
Intended use: Automated triage and guidance for questions and complaints related to sexually transmitted infections (STIs), based on self-reported symptoms and risk factors.
Software version: 1.1.23
Release date: 13-04-2026
Basic UDI-DI: to be provided
UDI-DI: to be provided

MANUFACTURER

ZIZ Foundation
Spijkermakersstraat 101a
2512 ET The Hague, The Netherlands
www.ziz.nl

CE MARKING

Pending completion of the ongoing certification process by Kiwa (NB 0344).
CE 0344 — Kiwa Nederland B.V., Notified Body under Regulation (EU) 2017/745 (MDR).

PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

Bas Mourik — bas.mourik@ziz.nl

INTENDED USER AND INTENDED USE ENVIRONMENT

- Individuals aged 12 years and older residing in the Netherlands
- Proficiency in the Dutch language is required
- For use on the user's own device in a private environment
- Compatible with the latest versions of Chrome, Safari, Firefox, and Edge

CONTRAINDICATIONS AND LIMITATIONS

This software is not suitable for:
- Individuals under the age of 12
- Acute medical complaints requiring immediate medical attention (such as fever or severe abdominal pain) — in an emergency, call 112 or contact your general practitioner or out-of-hours GP service.
- Replacing a medical consultation when PEP may be indicated — contact an STI clinic or HIV treatment centre directly within 72 hours after the risk exposure.
- Please note: this software provides guidance, not a medical diagnosis.

CLINICAL BENEFITS AND PERFORMANCE CHARACTERISTICS

This software helps users obtain appropriate advice on STI testing and follow-up steps more quickly and with fewer barriers, reduces unnecessary visits to healthcare providers, and improves access to STI care. The underlying decision rules are based on five Dutch clinical guidelines (NHG Guideline: The STI Consultation, Multidisciplinary STI Guideline, Dutch PrEP Guideline, Sexual Assault Guideline, and the Sexual Health Handbook). Performance characteristics for each clinical indication are described in the Clinical Evaluation Report (CER), available upon request via klantenservice@ziz.nl.

RESIDUAL RISKS AND WARNINGS

- The outcome of this consultation is guidance, not a medical diagnosis. If you have any doubts or persistent symptoms, always consult a healthcare professional.
- Use this software only on your own device in a private environment. Close the screen after use to protect your privacy.
- Do not use this software for medical emergencies.
- In the event of possible HIV exposure, PEP is only effective within 72 hours after the risk exposure. The software provides an automated indication, but it is the patient's responsibility to contact a healthcare professional within 72 hours.

HOW CAN I VERIFY THAT THE SOFTWARE IS WORKING CORRECTLY?

If the software is functioning correctly, you will see: (a) the welcome screen displaying the current software version, and (b) a summary advice screen at the end of the consultation. If you encounter error messages or a blank screen, refresh the page or contact klantenservice@ziz.nl.

CYBERSECURITY

Use only the official URL https://www.ziz.nl. Verify that the padlock icon is displayed in your browser's address bar. Suspicious messages or phishing attempts impersonating ZIZ can be reported via klantenservice@ziz.nl.

REPORTING INCIDENTS

Have you experienced a serious incident that you believe may be related to this software? Please report it:
- to ZIZ Foundation via klantenservice@ziz.nl, and
- to the Dutch Health and Youth Care Inspectorate (IGJ) via www.igj.nl → Reporting Centre.

COMPLAINTS

Complaints regarding this software or the associated services can be submitted using the contact form at www.ziz.nl/en/contact.

INSTRUCTIONS FOR USE (eIFU)

All relevant information, instructions for use, and explanations are provided electronically within the application itself. No separate printed or downloadable instructions for use are available.

PRIVACY

For information about the processing of your personal data, please refer to our Privacy Statement.

VERSION AND DOCUMENT HISTORY

Historical versions are available upon request via klantenservice@ziz.nl.